MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04,05 report with the FDA on 2008-01-04 for TDX/TDXFLX GENTAMICIN REAGENT 9512-60 manufactured by Abbott Diagnostics International, Ltd..
[17729261]
The customer contacted abbott to report a calibration error message "span less than min" for the tdx/tdx flx gentamicin assay on the tdx analyzer. The customer was sent a new lot of tdx gentamicin reagent. There was no impact to pt management reported by the customer.
Patient Sequence No: 1, Text Type: D, B5
[18009869]
This is an initial report. An investigation is in process. A final report will be submitted when the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2623532-2008-00001 |
| MDR Report Key | 973840 |
| Report Source | 01,04,05 |
| Date Received | 2008-01-04 |
| Date of Report | 2007-12-19 |
| Date of Event | 2007-12-10 |
| Date Mfgr Received | 2007-12-19 |
| Date Added to Maude | 2008-07-14 |
| 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 ROAD |
| 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 | 2008-01-04 |
| Model Number | NA |
| Catalog Number | 9512-60 |
| Lot Number | 51187Q100 |
| ID Number | NA |
| 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 | 976011 |
| 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 | 2008-01-04 |