MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-12-15 for ARCHITECT SIROLIMUS 01L76-25 manufactured by Abbott Laboratories.
[21768263]
The customer stated that the architect analyzer generated falsely elevated sirolimus results on one patient sample. The patient was switched to the drug everolimus, but the lab was not informed of the switch, so they ran the standing order for sirolimus. The sirolimus results provided were: 8. 3ng/ml. The customer believes the results should be <2. 0ng/ml. The date the last dose of sirolimus was administered to the patient - (b)(6) 2014. There was no reported impact to patient management. There was no additional patient information provided.
Patient Sequence No: 1, Text Type: D, B5
[21849723]
(b)(4). An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[33357468]
The investigation of the customer issue included a review of complaint text, a search for similar complaints, accuracy testing, and a review of labeling. The customer observed a discrepant result, while using architect sirolimus, list 1l76-25 lot 39012m500. A review of complaints for lot 39012m500 did not indicate any similar issue. There was no patient sample available to assist in the investigation. A review of the sirolimus assay product labeling provides adequate information regarding testing for sirolimus. It also provides discussion regarding limitations and performance of the sirolimus assay. Accuracy testing was performed to evaluate the performance of reagent lot 39012m500. An internal sirolimus panel was tested with retained kits of the reagent lot and all acceptance criteria was met, which indicates acceptable product performance. The infomation in the complaint text does not reasonably suggest a malfunction since an everolimus sample was tested on the architect sirolimus assay in error. No additional issues were identified; no further action is required at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2014-00244 |
| MDR Report Key | 4329397 |
| Report Source | 05 |
| Date Received | 2014-12-15 |
| Date of Report | 2014-11-20 |
| Date of Event | 2014-11-03 |
| Date Mfgr Received | 2015-03-06 |
| Device Manufacturer Date | 2014-06-01 |
| Date Added to Maude | 2014-12-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 224667-512 |
| Manufacturer G1 | ABBOTT LABORATORIES |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 60064350 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60064 3500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT SIROLIMUS |
| Generic Name | SIROLIMUS |
| Product Code | NRP |
| Date Received | 2014-12-15 |
| Catalog Number | 01L76-25 |
| Lot Number | 39012M500 |
| Device Expiration Date | 2015-10-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 60064350 US 60064 3500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-15 |