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.
[1080020]
The customer contacted abbott regarding failed calibration for the axsym rubella lgg assay where error code 1048 (calibration check failure, cal a/b, ratio too high) was generated. The customer had performed checks of the meia optics and bulk solution dispensers and was advised to perform decontamination procedures and recalibrate. After decontamination and recalibration, the same error message was obtained with another reagent lot. The customer reported no error messages in the instrument message history, and was advised to perform troubleshooting with the rubella negative control. The abbott field service representative (fsr) was dispatched to the customer site. The fsr replaced instrument parts and was able to achieve successful calibration, allthough the customer observed calibrator 1 values close to the upper limit. There was no impact to patient management reported by the customer.
Patient Sequence No: 1, Text Type: D, B5
[8253874]
(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 | 1415939-2008-00287 |
| MDR Report Key | 1341449 |
| Report Source | 01 |
| Date Received | 2009-03-12 |
| Date of Report | 2008-01-30 |
| Date of Event | 2008-01-29 |
| 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 | 55922M101 |
| ID Number | 56323M101 |
| 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 |