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.
[1072194]
The customer reported three unsuccessful attempts to calibrate the abbott axsym rubella lgg assay and observed elevated master calibrator rates with new rubella reagent and calibrators. The customer reported the sample and processing probes were replaced less than a year previous to the calibration issue and, recent checks of the instrument optics and decontamination of the instrument were performed. The customer was advised to perform tubing decontamination, replace the bulk mup solution, and replace both instrument probes. Despite the efforts by the customer, the rubella recalibration was unsuccessful. The customer was sent a new lot of reagents and standard and master calibrators. The customer attempted recalibration with the new lot of rubella reagent which was unsuccessful. The abbot field service representative was sent to the customer site. There was no impact to patient management reported by the customer.
Patient Sequence No: 1, Text Type: D, B5
[8222924]
(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 | 1415939-2008-00282 |
| MDR Report Key | 1341446 |
| Report Source | 01 |
| Date Received | 2009-03-12 |
| Date of Report | 2008-01-15 |
| Date of Event | 2008-01-08 |
| 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 | 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 |