MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2010-05-27 for IMX SIROLIMUS 5C91-83 manufactured by Abbott Laboratories.
[16120864]
(b)(4). 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. Suspect medical device, expiration date was corrected in this 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
[18283021]
(b)(4). The imx sirolimus calibration errors generated with reagent lot 802873106 are caused by a calibration curve ratio outside the imx sirolimus assay file limits for 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
[18372757]
The customer observed imx sirolimus calibration failures when reagent lot 802873106 was in use. The customer performed an optical check and system dispense check which were within specifications. The customer attempted recalibration on the same analyzer and another analyzer in the lab and calibration was not achieved. The customer performed recalibration which passed, however, error code 161 (check 5 out of range) was generated. The customer was sent a new lot of reagent, calibrator and pre-treatment solution. There was no impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-2010-00346 |
| MDR Report Key | 1700132 |
| Report Source | 01 |
| Date Received | 2010-05-27 |
| Date of Report | 2010-04-26 |
| Date of Event | 2010-04-26 |
| Date Mfgr Received | 2010-11-24 |
| Device Manufacturer Date | 2009-09-01 |
| Date Added to Maude | 2011-04-13 |
| 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 | 2010-05-27 |
| 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 | 2010-05-27 |