MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-11-08 for TDX/TDXFLX GENTAMICIN REAGENT 9512-60 manufactured by Abbott Diagnostics International, Ltd..
[730871]
Abbott axsym gentamicin reagents are demonstrating a decrease in the a calibrator to f calibrator span which may result in abbott gentamicin assay controls out of range. Abbott tdx/tdx flx gentamicin reagents were found to have a decrease in the calibrator a to f span which may produce error code "span less than min" and abbott gentamicin controls out of range. An investigation has been opened to identify the root cause of this issue.
Patient Sequence No: 1, Text Type: D, B5
[8015105]
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 | 2623532-2007-00491 |
| MDR Report Key | 939739 |
| Report Source | 07 |
| Date Received | 2007-11-08 |
| Date of Report | 2007-10-25 |
| Date of Event | 2007-10-25 |
| Date Mfgr Received | 2007-10-23 |
| Date Added to Maude | 2008-01-07 |
| 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 | DR. DAVID BARCH, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK RD. |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479379328 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2623532-11/7/07-008-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TDX/TDXFLX GENTAMICIN REAGENT |
| Generic Name | FOR THE QUANTITATIVE MEASUREMENT OF GENTAMICIN IN SERUM OR PLASMA |
| Product Code | LCQ |
| Date Received | 2007-11-08 |
| Model Number | NA |
| Catalog Number | 9512-60 |
| Lot Number | 51187Q100 |
| ID Number | 51189Q100 |
| Device Expiration Date | 2008-09-17 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 942129 |
| Manufacturer | ABBOTT DIAGNOSTICS INTERNATIONAL, LTD. |
| Manufacturer Address | KM 58.0, CARRETERA 2 CRUCE DAVILA BARCELONETA PR 00617 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-11-08 |