MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2007-11-05 for AXSYM QUINIDINE REAGENT 7A73-20 manufactured by Abbott Diagnostics International, Ltd..
[705609]
The customer stated that axsym quinidine results of >8 ug/ml were generated on a pt sample tested undiluted. Diluted axsym results were <0. 20 ug/ml which matched results generated using the tdx/flx quinidine assay. The customer stated that the sample was bright yellow/gold in appearance. No impact to pt management was reported.
Patient Sequence No: 1, Text Type: D, B5
[7896788]
This is an initial report. An investigation is in progress. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2623532-2007-00503 |
| MDR Report Key | 938423 |
| Report Source | 04,05 |
| Date Received | 2007-11-05 |
| Date of Report | 2007-10-07 |
| Date of Event | 2007-10-07 |
| Date Mfgr Received | 2007-10-07 |
| Device Manufacturer Date | 2007-06-01 |
| Date Added to Maude | 2007-12-31 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXSYM QUINIDINE REAGENT |
| Generic Name | QUANTITATIVE MEASUREMENT OF QUNINDINE |
| Product Code | LBZ |
| Date Received | 2007-11-05 |
| Model Number | NA |
| Catalog Number | 7A73-20 |
| Lot Number | 54588Q100 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 936312 |
| 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 | 2007-11-05 |