MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-06-20 for AXSYM QUINIDINE CALIBRATORS 7A73-01 manufactured by Abbott Diagnostics International, Ltd..
[651925]
Axsym and xsystems quinidine calibrators and controls are exhibiting a loss of concentration after 9 to 10 months of dating. This loss of concentration is resulting in controls out of specification results. When controls and calibrators that are past 9 to 10 months of dating are run together, control results are within specifications; however, results may be falsely elevated.
Patient Sequence No: 1, Text Type: D, B5
[7966840]
Continued: axsym quinidine calibrators, list # 7a73-01, lot #: 44794q100, exp: 08/09/07 and 4244q100, exp : 5/17/07. Axsym quinidine controls, list # 7a73-10, lot #: 40454q100, exp : 04/04/07, 43273q100, exp: 6/23/07 and 47028q100 exp: 10/14/07. X-systems quinidine controls, list # 9506-10, lot #: 41743q100, exp : 4/13/07, 44161q100, exp: 8/23/07 46295q100, exp : 8/23/07, 48293q100, exp : 1/04/08 and 50238q100, exp : 5/20/07. X-systems quinidine calibrators, list # 9506-01, lot # : 42442q100, exp: 7/17/07, 44791q100, exp : 10/09/07, 46753q100, exp: 12/10/07, 48107q100, exp: 10/9/07 50236q100, exp: 4/21/08 and 51591q100, exp : 4/21/08. 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 | 2623532-2007-00303 |
| MDR Report Key | 867837 |
| Report Source | 05 |
| Date Received | 2007-06-20 |
| Date of Report | 2007-05-29 |
| Date of Event | 2007-05-22 |
| Date Mfgr Received | 2007-05-29 |
| Date Added to Maude | 2007-06-28 |
| 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 | NO |
| Previous Use Code | 3 |
| Removal Correction Number | 2623532-6/12/07-006-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXSYM QUINIDINE CALIBRATORS |
| Generic Name | QUANTITATIVE MEASUREMENT OF QUINIDINE |
| Product Code | LBZ |
| Date Received | 2007-06-20 |
| Model Number | NA |
| Catalog Number | 7A73-01 |
| Lot Number | 47093Q100 |
| ID Number | NA |
| Device Expiration Date | 2007-10-10 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 850487 |
| 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 | 2007-06-20 |