MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2011-02-15 for CLIN CHEM ALBUMIN BCG REAGENT 7D53-21 manufactured by Abbott Manufacturing, Inc..
[15538432]
The customer observed clinical chemistry albumin bcg controls out of range when reviewing the night shift's quality control data. The customer determined patient results were reported out of the lab when the albumin controls were out of range. The customer sent calibration data, levy-jennings data and patient data to abbott for evaluation. The customer successfully recalibrated the albumin assay with the quality controls within specification and re-assayed patient samples from the run with controls out of range. An example of the patient data is as follows: initial result: 3. 1 g/dl, repeat result: 4. 3 g/dl the initial patient result and a corrected patient result was reported out of the lab, however, there was no impact to patient management.
Patient Sequence No: 1, Text Type: D, B5
[15825628]
(b)(4). Concomitant medical products: architect analyzer, list #1g06-01, (b)(4). The cause of the particulate matter ((b)(4), a fungal species found in the environment) observed in some clinical chemistry (b)(4) 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 | 2018433-2011-00001 |
| MDR Report Key | 1991224 |
| Report Source | 00 |
| Date Received | 2011-02-15 |
| Date of Report | 2010-03-18 |
| Date of Event | 2010-01-29 |
| Date Mfgr Received | 2010-03-18 |
| Date Added to Maude | 2012-02-07 |
| 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 | 2011-02-15 |
| Catalog Number | 7D53-21 |
| Operator | OTHER |
| Device Availability | Y |
| 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 | 2011-02-15 |