MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2012-12-10 for CLINICAL CHEMISTRY PHENOBARBITAL 01E08-21 manufactured by Abbott Manufacturing Inc.
[2988551]
The customer observed fluctuations in calibration for phenobarbital on an architect c8000 analyzer. There was no adverse impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[10335490]
(b)(4). The investigation determined three lots of phenobarbital reagent (52803un12, 62299un12, and 85773un12) have exhibited increased imprecision associated with the aging of the reagents. The issue is driven by flocculation in the r2 reagent. Customers have been instructed to discontinue use of these three lots and destroy any remaining inventory. A replacement lot with reduced dating is available to customers.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1628664-2012-00505 |
| MDR Report Key | 2863526 |
| Report Source | 01 |
| Date Received | 2012-12-10 |
| Date of Report | 2012-11-12 |
| Date Mfgr Received | 2012-11-30 |
| Device Manufacturer Date | 2012-07-31 |
| Date Added to Maude | 2013-01-09 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 847937-512 |
| Manufacturer G1 | ABBOTT MANUFACTURING INC |
| Manufacturer Street | 1921 HURD DRIVE |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75038 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1628664-11/19/12-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINICAL CHEMISTRY PHENOBARBITAL |
| Product Code | LGQ |
| Date Received | 2012-12-10 |
| Catalog Number | 01E08-21 |
| Lot Number | 85773UN12 |
| Device Expiration Date | 2013-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING INC |
| Manufacturer Address | 1921 HURD DRIVE IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-10 |