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 5C91-21 manufactured by Abbott Laboratories.
[1504422]
The customer observed imx sirolimus error code 107 (cal level sense error) when reagent lot 802873106 was in use. The customer performed an optics and dispense check which passed. The customer was informed of the product recall for this imx sirolimus reagent lot and was sent a new lot of reagent. There was no impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[8632196]
(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 | 1415939-2010-00350 |
| MDR Report Key | 1710929 |
| Report Source | 01 |
| Date Received | 2010-06-04 |
| Date of Report | 2010-05-12 |
| Date of Event | 2010-05-12 |
| Date Mfgr Received | 2010-06-11 |
| Date Added to Maude | 2010-08-27 |
| 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 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 | 5C91-21 |
| Lot Number | 802873106 |
| Device Expiration Date | 2010-07-23 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 |