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.
[1079549]
The customer contacted abbott for two calibration failures for the axsym rubella lgg assay where error codes 1006 (calibration check failure, cal d, deviation too large) and 1018 (calibration check failure, cal a, result too high) were generated. The customer stated axsym maintenance was performed regularly, and the customer was advised to replace the sample probe. After sample probe replacement, the customer reported a successful rubella calibration was achieved, although the rubella negative control was 0. 7 instead of zero. The customer recalibrated with the same reagent lot and obtained error code 1018 again. The customer was advised to centrifuge the calibrator and recalibration of the assay was acceptable. The customer was sent a new lot of reagent and recalibration with the new reagent failed. There was no impact to patient management reported by the customer.
Patient Sequence No: 1, Text Type: D, B5
[8253868]
(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 | 1415939-2008-00290 |
| MDR Report Key | 1341436 |
| Report Source | 01 |
| Date Received | 2009-03-12 |
| Date of Report | 2008-02-01 |
| Date of Event | 2008-01-31 |
| 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 | UNK |
| 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 |