MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2010-05-04 for CLIN CHEM ALBUMIN BCG REAGENT 7D53-21 manufactured by Abbott Manufacturing, Inc..
[18593461]
(b)(4). Concomitant medical products: architect c8000 analyzer, 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
[18611356]
The customer observed clinical chemistry albumin bcg quality control results below peer range after switching to the reformulated albumin reagents. The customer did not observe this issue with other assays. The customer provided precision data for evaluation and also provided the following example of patient results as follows: original reagent: 4. 28 g/dl, reformulated reagent 4. 51 g/dl. The customer also performed some recommended troubleshooting and was asked to monitor the issue. There was no impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[21744342]
(b)(4). Suspect medical device, lot number, expiration date: an incorrect suspect medical device, lot number, expiration date was submitted in the initial medwatch submission. The expiration date has been corrected to 10/15/11. Upon further review, the customer's issue is not associated with remedial action 2018433-3/11/10-001-r, and is unassigned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2018433-2010-00073 |
| MDR Report Key | 1672839 |
| Report Source | 00 |
| Date Received | 2010-05-04 |
| Date of Report | 2010-03-12 |
| Date of Event | 2010-03-12 |
| Date Mfgr Received | 2011-01-19 |
| Date Added to Maude | 2010-12-10 |
| 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 | 2010-05-04 |
| Catalog Number | 7D53-21 |
| Lot Number | 83030HW00 |
| Device Expiration Date | 2011-10-15 |
| 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 | 2010-05-04 |