MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2009-03-12 for AXSYM RUBELLA LGG ANTIBODY 3B23-20 manufactured by Abbott Laboratories.
[1072327]
The customer stated that the axsym rubella lgg reagent calibration failed twice with an error code on the axsym analyzer that indicated the m-cal 1 response was too large. The customer received a new calibrator lot and recalibrated successfully. No impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[8223444]
(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 | 1415939-2008-00266 |
| MDR Report Key | 1341452 |
| Report Source | 01,05 |
| Date Received | 2009-03-12 |
| Date of Report | 2008-04-21 |
| Date of Event | 2008-04-18 |
| 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 | 56659M201 |
| ID Number | NA |
| Device Expiration Date | 2008-07-21 |
| Operator | HEALTH PROFESSIONAL |
| 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 |