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.
[1079550]
The customer contacted abbott regarding master calibration error code 1061 (master calibration failure, incomplete calibrator results) for the axsym rubella lgg assay. The customer reported that another failed calibration occurred in 2008 with calibration deviation too large between two points. The customer was advised to replace and calibrate the sample probe and attempt recalibration. The customer reported recalibration failed and error code 1048 (calibration check failure, cal a/b, ratio too large) was generated. The customer was advised to centrifuge the calibrators and recalibrate. Recallibration of the rubella lgg assay was successful after calibrator centrifugation and quality controls were in range. There was no impact to patient management reported by the customer.
Patient Sequence No: 1, Text Type: D, B5
[8253869]
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 | 1415939-2008-00292 |
| MDR Report Key | 1341438 |
| Report Source | 01 |
| Date Received | 2009-03-12 |
| Date of Report | 2008-02-04 |
| Date of Event | 2008-02-01 |
| 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 | 56323M101 |
| ID Number | UNK |
| 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 |