MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2007-11-08 for CLINICAL CHEMISTRY PHENYTOIN 1E07-20 manufactured by Abbott Manufacturing, Inc..
[712761]
The customer states, that falsely elevated results were generated for one patient sample using architect c8000 phenytoin assay. No suspect results were reported from the lab. The customer states, that in 2007, at 15:58 hrs, the sample from this patient read 72, 81, and 106 umol/l. At 17:20 hrs, the sample read 69, 69, 69, 67 and 67 umol/l. At 22:36 hrs, the sample read 77, 79, 77, 78, and 80 umol/l. The following day, the patient generated a result of 72 umol/l. At 09:27 hrs a result of 95 umol/l was generated. At 11:57 hrs, one sample generated results of 77, 81, 79 and 95 umol/l. The customer states, that the phenytoin assay is the only assay with this precision issue. Controls have remained within specifications. There is no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[8011231]
This is an initial report. A final report will be submitted at the conclusion of an investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2018433-2007-00233 |
| MDR Report Key | 938887 |
| Report Source | 01 |
| Date Received | 2007-11-08 |
| Date of Report | 2007-10-15 |
| Date of Event | 2007-10-10 |
| Date Mfgr Received | 2007-10-15 |
| Device Manufacturer Date | 2007-04-01 |
| 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 |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| 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 | CLINICAL CHEMISTRY PHENYTOIN |
| Generic Name | QUANTITATION OF PHENYTOIN IN HUMAN SERUM OR PLASMA |
| Product Code | LES |
| Date Received | 2007-11-08 |
| Model Number | NA |
| Catalog Number | 1E07-20 |
| Lot Number | 52013HW00 |
| ID Number | NA |
| Device Expiration Date | 2009-02-28 |
| 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 | 939654 |
| Manufacturer | ABBOTT MANUFACTURING, INC. |
| Manufacturer Address | 820 MISSION ST. SOUTH PASADENA CA 91030 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-11-08 |