MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-26 for ARCHITECT SIROLIMUS 01L76-25 manufactured by Abbott Laboratories.
[54149757]
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
[54149760]
The customer stated that patients being treated with everolimus test positive for sirolimus on the architect analyzer. On (b)(6) 2016 a patient being treated with everolimus generated a positive sirolimus result by architect, but a result of <0. 9ng/ml on the uplc mass spec. There was no reported impact to patient management. There was no additional patient information provided.
Patient Sequence No: 1, Text Type: D, B5
[55734490]
The investigation of the customer issue included a review of complaint text, a search for similar complaints, and a review of labeling. The customer observed a falsely elevated sirolimus result, while using architect sirolimus, list 1l76-25 lot 50170m500, on patients being treated with everolimus. A review of complaints for lot 50170m500 did not indicate any similar issue or trend. There was no patient sample available to assist in the investigation. A review of the sirolimus assay product labeling shows adequate information regarding testing and regarding limitations and performance of the assay. The information in the complaint text does not reasonably suggest a malfunction since an everolimus sample was purposely tested on the architect sirolimus assay. Based on the investigation the architect sirolimus reagent, lot 50170m500, is performing as intended and no product issues or malfunctions were identified.
Patient Sequence No: 1, Text Type: N, H10
[76838178]
The device evaluation was reassessed and concluded that a malfunction occurred, therefore the device was not performing as intended, and conclusions code was corrected in evaluation codes from (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2016-00089 |
| MDR Report Key | 5906437 |
| Date Received | 2016-08-26 |
| Date of Report | 2017-05-22 |
| Date of Event | 2016-08-02 |
| Date Mfgr Received | 2017-05-22 |
| Device Manufacturer Date | 2015-10-01 |
| Date Added to Maude | 2016-08-26 |
| 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 | 3 |
| Event Location | 3 |
| 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 600643500 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600643500 |
| 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 | 2016-08-26 |
| Catalog Number | 01L76-25 |
| Lot Number | 50170M500 |
| Device Expiration Date | 2017-02-03 |
| 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 600643500 US 600643500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-26 |