MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-07-10 for XSYSTEMS QUINIDINE CALIBRATORS 9506-01 manufactured by Abbott Diagnostics International, Ltd..
[647364]
The customer stated that while calibrating the tdxflx quinidine assay, they observed a shift in controls that was within the lower limit of the range listed in the package insert. The issue was not resolved by recalibrating with another reagent, calibrator and control kit from the same lot. There was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[7903605]
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 | 2623532-2007-00446 |
| MDR Report Key | 877025 |
| Report Source | 04 |
| Date Received | 2007-07-10 |
| Date of Report | 2007-06-28 |
| Date of Event | 2007-03-09 |
| Date Mfgr Received | 2007-06-28 |
| Date Added to Maude | 2007-12-21 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DR. DAVID BARCH |
| 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 | OT |
| Previous Use Code | 3 |
| Removal Correction Number | 2623532-6/12/07-006-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XSYSTEMS QUINIDINE CALIBRATORS |
| Generic Name | FOR THE STANDARD CALIBRATION OF THE QUINIDINE ASSAY ON THE TDXFLX OR TDX SYSTEM |
| Product Code | LBZ |
| Date Received | 2007-07-10 |
| Model Number | NA |
| Catalog Number | 9506-01 |
| Lot Number | 44791Q100 |
| ID Number | NA |
| Device Expiration Date | 2007-10-09 |
| 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 | 936827 |
| 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 | 2007-07-10 |