MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2010-06-04 for IMX SIROLIMUS 5C91-83 manufactured by Abbott Laboratories.
[8909409]
(b)(4). Suspect medical device, expiration date: the correct expiration date of imx sirolimus reagent lot 802873106 is 5/13/10, not 7/23/10 as was submitted in the initial medwatch submission. The imx sirolimus calibration errors generated with reagent lot 802873106 were caused by a calibration curve ratio outside the imx sirolimus assay file limits for the imx sirolimus calibrator b/calibrator a and calibrator f/calibrator a. A product recall was issued and a letter was sent to abbott customers with instructions to discontinue use and destroy the suspect imx sirolimus reagent and switch to a replacement lot of reagent.
Patient Sequence No: 1, Text Type: N, H10
[16639060]
The customer observed imx sirolimus calibration failure code 161 (check 5 out of range) when reagent lot 802873106 was in use. The customer performed a passing photo check, however, the analyzer dispense check failed, therefore, the customer was advised to change the diluent syringe and perform a probe decontamination. The customer achieved a successful recalibration on a different analyzer in the lab. There was no impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[16663566]
(b)(4). This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2010-00349 |
| MDR Report Key | 1710928 |
| Report Source | 01 |
| Date Received | 2010-06-04 |
| Date of Report | 2010-04-23 |
| Date of Event | 2010-04-23 |
| Date Mfgr Received | 2010-11-24 |
| Device Manufacturer Date | 2009-09-01 |
| Date Added to Maude | 2010-12-10 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NOEMI KONDOS RN, BSN |
| Manufacturer Street | 200 ABBOTT PARK ROAD DEPT. 09B9, AP50 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 8479375120 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1415939-5/3/10-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMX SIROLIMUS |
| Generic Name | FOR THE QUANTITATIVE DETERMINATION OF SIROLIMUS IN HUMAN WHOLE BLOOD |
| Product Code | NRP |
| Date Received | 2010-06-04 |
| Catalog Number | 5C91-83 |
| Lot Number | 802873106 |
| Device Expiration Date | 2010-05-13 |
| Operator | OTHER |
| Device Availability | Y |
| 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 | 2010-06-04 |