UKRG Handbook
DEFECTIVE PRODUCT REPORTS
|
Product
|
No. of Reports
|
Nature of problem
|
|
| Technetium generator |
23
|
Reduced elution yield; Damaged elution vial |
|
| MAA |
7
|
Black particles seen in vial | |
|
2
|
Wrong particle size after reconstitution | ||
|
1
|
Glass particle seen in vial | ||
|
1
|
Fibre seen after reconstitution | ||
| Sodium (131I)Iodide Therapy capsule |
4
|
Reference activity wrongly stated | |
| Sodium (131I) Iodide Solution |
2
|
Radioactive concentration wrongly stated | |
| Tetrofosmin |
1
|
Reduced radiochemical purity | |
|
1
|
Inconsistency of batch numbers | ||
|
2
|
Lack of myocardial uptake | ||
| DTPA |
1
|
Excessive quantity of lyophilate in vial | |
|
1
|
Vial damaged on receipt | ||
| Thallous (201Tl) chloride |
1
|
Measured activity and volume low | |
|
1
|
Vial damaged on receipt | ||
| Exametazime kits |
1
|
Not correctly packed before despatch | |
| Human albumin kits |
1
|
Vial broken on receipt. Incorrect packaging used | |
| MAG-3 |
1
|
Vial cracked during boiling | |
| Medronate |
1
|
Reduced radiochemical purity | |
| Pyrophosphate |
1
|
Damaged vial | |
| Rhenium sulphide |
1
|
Reduced radiochemical purity | |
| Dicopac |
1
|
Poor sealing of packaging | |
| Gallium (67Ga) citrate |
1
|
Foreign body seen in solution | |
| Indium (111In) DTPA |
1
|
Wrong package insert | |
| Iodine (123I) b-CIT |
1
|
Wrong volume stated on label | |
| Iodine (131I) iodohippurate |
1
|
Package insert was for 123I-iodohippurate | |
| Samarium (153Sm) EDTMP |
1
|
Activity received lower than ordered | |
A total of 60 reports were received. Elution problems with technetium generators remain the most frequent report, 23 such reports were received which spread accross the range of manufacturers. Reduced or no radioactive yield was frequently reported. The volume eluted was also found to differ from that anticipated. There were two reports of elution vials breaking after elution. There was a large number of reports of black particles being observed in vials of MAA after reconstitution. Errors and inconsistencies in the documentation provided by manufacturers were reported for eight products. Reduced radiochemical purity was reported for three technetium kit products.
There were eight reports of problems with cell labelling procedures. Five reports of reduced labelling efficiency of leucocytes using technetium exametazime were received. One possible explanation was the medication currently being taken by the patients. Drugs possibly implicated in reduced labelling were gold, cephalexin, cefuroxime, metronidazole, prednisolone, omeprazole, lisinopril and aspirin. Three reports of failure of in vivo erythrocyte labelling, using administration of inactive stannous ion followed by 20-30 min later by pertechnetate, were received. In one instance, the images suggested the presence of pertechnetate, with the stomach being visualised. This suggests the stannous ion reduction of pertechnetate failed to occur. The investigation was repeated the following day with the same outcome. The same batch of stannous agent had, however, been used without problems in other patients. In the other two cases, the images did not suggest the presence of pertechnetate, but the biodistribution was not typical of labelled erythrocytes. There was marked renal excretion of radioactivity and in one patient, who was taking ferrous sulphate, there was also uptake in liver and spleen. The possibility of chelation of technetium into an iron complex which is renally excreted is a possibility.