MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-09-02 for SESTAMIBI manufactured by Pharmalogic.
[2240472]
Pharmalogic reported on (b)(6) 2011 that they were aware of a altered biodistribution issue with sestamibi-r- due to a generator malfunction. Lot affected was 1134. Product passed the company's qi and assayed for the correct amounts of sestamibi-r-. However, affected pt's heart was unable to be visualized on nuclear scan during cardiac stress testing due to the increased uptake by of the radioisotope by the stomach and bowel. Patient did not suffer any harm, but is inconvenienced by having the test repeated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5022123 |
| MDR Report Key | 2240770 |
| Date Received | 2011-09-02 |
| Date of Report | 2011-09-02 |
| Date of Event | 2011-08-24 |
| Date Added to Maude | 2011-09-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SESTAMIBI |
| Generic Name | SESTAMIBI |
| Product Code | KTA |
| Date Received | 2011-09-02 |
| Lot Number | 1134 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHARMALOGIC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-09-02 |