MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-12-04 for CLINICAL CHEMISTRY PHENOBARBITAL 1E08-20 manufactured by Abbott Mfg, Inc.
[554113]
Abbott has identified a phenobarbital performance issue that is demonstrated by erratic elevated results and/or the inability to calibrate due to imprecision. A recall was issued and reported under 21 cfr 806 to the fda district office on september 28, 2006. Abbott has not received any report of adverse events associated with this issue.
Patient Sequence No: 1, Text Type: D, B5
[7917432]
This is a final report. An investigation is in-process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2018433-2006-00028 |
| MDR Report Key | 793876 |
| Report Source | 07 |
| Date Received | 2006-12-04 |
| Date of Event | 2006-09-28 |
| Date Added to Maude | 2006-12-14 |
| 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 | 3 |
| 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 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2018433-9/28/06-002-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINICAL CHEMISTRY PHENOBARBITAL |
| Generic Name | QUANTITATION OF PHENOBARBITAL IN HUMAN SERUM OR PLASMA |
| Product Code | LGQ |
| Date Received | 2006-12-04 |
| Model Number | NA |
| Catalog Number | 1E08-20 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | NOT APPLICABLE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 781493 |
| Manufacturer | ABBOTT MFG, INC |
| Manufacturer Address | 820 MISSION ST. SOUTH PASADENA CA 91030 US |
| Baseline Brand Name | CLINICAL CHEMISTRY PHENOBARBITAL |
| Baseline Generic Name | QUANTITATION OF PHENOBARBITAL IN HUMAN SERUM OR PLASMA |
| Baseline Model No | NA |
| Baseline Catalog No | 1E08-20 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-12-04 |