MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2010-04-12 for CLIN CHEM ALBUMIN BCG REAGENT 7D53-21 manufactured by Abbott Manufacturing, Inc..
[16094333]
(b)(4). Concomitant medical products:architect c8000 analyzers, list # 1g06-01, (b)(4). This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[16254198]
The customer observes a difference in clinical chemistry albumin values when they switched to reagent lot 80051hw00. The customer provided verification of the albumin assay configuration and calibration set points, however, declined to configure the assay correlation factor so, assay results would match. The customer stated maintenance was up to date and provided calibrations for review by abbott. From the calibration data, it was determined the customer was using the incorrect set points for the albumin calibrators. The customer performed the recommended troubleshooting procedures, and the issue was resolved with the reconfiguration of the calibrator set points. There was no impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2018433-2010-00065 |
| MDR Report Key | 1656701 |
| Report Source | 00 |
| Date Received | 2010-04-12 |
| Date of Report | 2010-03-12 |
| Date of Event | 2010-03-12 |
| Date Mfgr Received | 2010-04-14 |
| Date Added to Maude | 2010-11-04 |
| 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 | 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 MANUFACTURING, INC. |
| Manufacturer Street | 820 MISSION ST. |
| Manufacturer City | SOUTH PASADENA CA 91030 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91030 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2018433-3/11/10-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLIN CHEM ALBUMIN BCG REAGENT |
| Generic Name | QUANTITATION OF ALBUMIN IN HUMAN SERUM OR PLASMA |
| Product Code | CIX |
| Date Received | 2010-04-12 |
| Catalog Number | 7D53-21 |
| Lot Number | 80051P100 |
| Device Expiration Date | 2010-07-15 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MANUFACTURING, INC. |
| Manufacturer Address | 820 MISSION ST. SOUTH PASADENA CA 91030 US 91030 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-04-12 |