MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2009-03-12 for AXSYM RUBELLA LGG ANTIBODY 3B23-20 manufactured by Abbott Laboratories.
[1049854]
The customer observed axsym calibration error code 1018 ( calibration check failure, calibrator a, result too high) for the axsym rubella lgg assay. The customer attempted to calibrate the rubella assay six times without success and was sent a new lot of rubella lgg calibrator, and the issue was resolved. The abbott field service representative (fsr) was at the customer site and the suspect reagents were tested at another cusotmer site and were determined not to be the cause of the issue. In troubleshooting the issue, the customer assayed the calibrators from a previously stored calibratioin curve, then replaced calibrator a with the rubella negative control and achieved a successful calibration. The customer was sent new rubella calibrators and the calibration failed again. The customer sent the reagents to another customer site for testing and calibratoin was accepted. The fsr replaced the optical standard, recalibrated the optics, checked the bulk mup and the matrix carousel. Upon completion of the troubleshooting procedures, a successful rubella calibration was achieved. There was no impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[8223447]
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 | 1415939-2008-00275 |
| MDR Report Key | 1341461 |
| Report Source | 01 |
| Date Received | 2009-03-12 |
| Date of Report | 2007-11-12 |
| Date of Event | 2007-11-09 |
| Date Mfgr Received | 2008-06-02 |
| Date Added to Maude | 2009-03-12 |
| 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 | KHAUDEJA BANO |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646112 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646112 |
| Manufacturer Phone | 8479386319 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | 1415939-6/06/08-004-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXSYM RUBELLA LGG ANTIBODY |
| Generic Name | MEIA FOR THE MEASUREMENT OF LGG ANTIBODY TO THE RUBELLA VIRUS |
| Product Code | GOL |
| Date Received | 2009-03-12 |
| Model Number | NA |
| Catalog Number | 3B23-20 |
| Lot Number | 52563M100 |
| ID Number | NA |
| Device Expiration Date | 2008-06-30 |
| Operator | OTHER |
| Device Availability | Y |
| 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 | 2009-03-12 |