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.
[1080018]
The customer reported failed calibration with the abbott axsym rubella lgg assay, as calibrator a was too high. The customer was able to successfully recalibrate using bulk solution 3 instead of the rubella calibrator a. The customer was sent rubella calibrators and controls and upon recalibration with the new calibrators, a successful rubella lgg calibration was achieved. There was no impact to patient management reported by the customer.
Patient Sequence No: 1, Text Type: D, B5
[8253872]
(no consequence or impact to patient). (calibration error). (error message given) 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 | 1415939-2008-00281 |
MDR Report Key | 1341445 |
Report Source | 01 |
Date Received | 2009-03-12 |
Date of Report | 2008-01-15 |
Date of Event | 2008-01-14 |
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 | 55922M100 |
ID Number | NA |
Device Expiration Date | 2008-06-20 |
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 |