MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-03-31 for CLIN CHEM ALBUMIN BCG REAGENT 7D53-21 manufactured by Abbott Manufacturing, Inc..
[1294514]
The customer observed elevated clinical chemistry albumin bcg control values and patient results that were generated from the architect c8000 analyzer when reagent lot 80051hw00 was in use. The customer stated the albumin results varied when new albumin reagent of the same lot number was put into service. The customer recalibrated the albumin assay and re-assayed the patient samples. The customer provided an example of the elevated patient results before and after the albumin assay recalibration. Initial result: 6. 6 g/dl, repeat result: 4. 8 g/dl. The customer reported the suspect patient result out of the lab, however, there was no impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[8592294]
(b)(4). Concomitant medical device: architect c8000 analyzer, list # 1g06-11, (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
[16420509]
(b)(4): architect analyzer, list # 1g06-11, serial # (b)(4). The cause of the particulate matter ((b)(6), a fungal species found in the environment) observed in some clinical chemistry albumin bcg reagent cartridges was due to exposure of the albumin bcg formula containing weak antimicrobial additive from normal formulation and filtering processes designed for microbial growth controlled clinical chemistry reagents. Abbott issued a product recall advising customers to discard or destroy any inventory of three affected lots of clinical chemistry albumin bcg reagents. Abbott is identifying alternate formulation for the clinical chemistry albumin reagents that contain no mercury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2018433-2010-00046 |
| MDR Report Key | 1647241 |
| Report Source | 05 |
| Date Received | 2010-03-31 |
| Date of Report | 2010-03-04 |
| Date of Event | 2010-03-04 |
| Date Mfgr Received | 2011-01-19 |
| Device Manufacturer Date | 2009-07-15 |
| Date Added to Maude | 2010-10-06 |
| 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 | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| 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 | 2010-03-31 |
| Catalog Number | 7D53-21 |
| Lot Number | 80051HW00 |
| Device Expiration Date | 2011-07-15 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2010-03-31 |