MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2008-04-30 for AXSYM GENTAMICIN 7A65-20 manufactured by Abbott Diagnostics International, Ltd..
[853344]
The customer contacted abbott after receipt of abbott's customer letter regarding axsym gentamicin reagent performance. The customer stated they had been using the reagent lot in question for quite a while and observed abbott quality controls quickly drifting out of range high. The abbott customer service representative requested the customer fax calibration and quality control data to abbott for data review. The customer stated the assay performance is acceptable after changing the lot of axsym gentamicin reagent and there was no impact to pt management.
Patient Sequence No: 1, Text Type: D, B5
[8060006]
An investigation was conducted for the abbott axsym and tdx/tdxflx gentamicin reagents. The abbott axsym and tdx/tdxflx gentamicin reagents share the same antibody and tracer stock concentrates. A decrease in the calibrator a-f span was observed with the tdx/tdxflx gentamicin reagents resulting in tdx/tdxflx gentamicin calibration failures (span less than minimum span). Although there was an apparent decrease in the axsym gentamicin reagent calibrator a-f span, this issue did not result in a calibration failure. Nevertheless, individual replicates of the medium control level out of specification (oos) flags were generated during stability for two time points. For the axsym gentamicin reagent lots, since there was a potential the calibrator a-f span could result in calibration failures, a decision was made to reduce the expiration date for the axsym gentamicin reagents, however, the data from the investigation supports the axsym gentamicin reagent lots were not impacted and performed as expected. Stability testing monitored axsym gentamicin reagent until the last test point, which was one month beyond the reagent's expiration date. The calibrator a-f span did not continue to decrease; instead, it increased, supporting there was not a true decrease in calibrator a-f span for the axsym gentamicin reagent. With respect to the axsym gentamicin medium control oos results, none of the subsequent test points showed control oos until the last test point. Statistical eval (assay capability) along with these new test points support that replicates of medium control oos results were related to the expected assay variability, therefore, there were no preventive actions warranted for the axsym gentamicin assay.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2623532-2008-00011 |
| MDR Report Key | 1036541 |
| Report Source | 01,04 |
| Date Received | 2008-04-30 |
| Date of Report | 2008-04-07 |
| Date of Event | 2007-11-05 |
| Date Mfgr Received | 2008-04-07 |
| Device Manufacturer Date | 2007-05-01 |
| Date Added to Maude | 2009-08-06 |
| 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 | SUDARSHAN HEBBAR, MD, D-3MQC, AP6B |
| Manufacturer Street | 100 ABBOTT PARK RD. |
| Manufacturer City | ABBOTT PARK IL 600646112 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646112 |
| Manufacturer Phone | 8479379677 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | 2623532-11/7-07-009-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXSYM GENTAMICIN |
| Generic Name | FOR THE QUANTITATIVE MEASUREMENT OF GENTAMICIN IN SERUM OR PLASMA |
| Product Code | LCQ |
| Date Received | 2008-04-30 |
| Model Number | NA |
| Catalog Number | 7A65-20 |
| Lot Number | 53190Q100 |
| ID Number | 58600Q100 |
| Device Expiration Date | 2008-04-12 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIAGNOSTICS INTERNATIONAL, LTD. |
| Manufacturer Address | KM 58.0, CARRETERA 2 CRUCE DAVILA BARCELONETA PR 00617 US 00617 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-30 |