MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2010-02-23 for AXSYM PHENYTOIN 7A67-20 manufactured by Abbott Diagnostics Int'l, Ltd.
[1318185]
The customer stated that samples from one patient tested on different dates ((b)(6)) generated discrepant axsym phenytoin results. For example, an initial result of 0. 59 ug/ml was repeated at 0. 45 ug/ml, reported out of the lab and was questioned by the patient's physician as it was lower than expected. The same sample was then retested with a result of more than 40 ug/ml. Stored samples from the same patient were sent to a reference lab (axsym system) and results between 24. 32 ug/ml and more than 40 ug/ml were generated. Quality controls were all within the expected ranges and there was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[8444209]
(b)(4). This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete. An investigation is in process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2623532-2010-00008 |
| MDR Report Key | 1611994 |
| Report Source | 01,05 |
| Date Received | 2010-02-23 |
| Date of Report | 2010-01-27 |
| Date of Event | 2010-01-26 |
| Date Mfgr Received | 2010-03-17 |
| Device Manufacturer Date | 2009-05-22 |
| Date Added to Maude | 2011-10-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NOEMI KONDOS RN, BSN |
| Manufacturer Street | 200 ABBOTT PARK ROAD DEPT. 09B9, AP50 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 8479375120 |
| Manufacturer G1 | ABBOTT DIAGNOSTICS INT'L, LTD |
| Manufacturer Street | KM 58.0 CARRETERA 2 CRUCE DAVILA |
| Manufacturer City | BARCELONETA PR 00617 |
| Manufacturer Postal Code | 00617 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXSYM PHENYTOIN |
| Generic Name | FOR THE MEASUREMENT OF PHENYTOIN IN HUMAN SERUM OR PLASMA |
| Product Code | LGR |
| Date Received | 2010-02-23 |
| Catalog Number | 7A67-20 |
| Lot Number | 74550Q100 |
| Device Expiration Date | 2010-02-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIAGNOSTICS INT'L, LTD |
| Manufacturer Address | KM 58.0 CARRETERA 2 CRUCE DAVILA BARCELONETA PR 00617 00617 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-02-23 |