MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-11-18 for IMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT) IMMAGE AAT REAGENT 447740 manufactured by Beckman Coulter, Inc..
[2352587]
Customer called to report that the immage 800 immunochemistry system generated erroneous alpha-antitrypsin (aat) results. Customer also reported low quality control recovery. The root cause could not be determined; however, it appears as though this was a reagent-specific issue, and not an instrument issue, as the problems occurred once this reagent lot was used. A service request was not generated. Customer stated that although erroneous results were generated, patient treatment was not affected.
Patient Sequence No: 1, Text Type: D, B5
[9485002]
The root cause of the issue was not determined, but it appears as though the issue was reagent-specific. (note: the beckman coulter, inc. Identifier for this report is (b)(4)). Reagent-specific issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-07625 |
| MDR Report Key | 2342629 |
| Report Source | 01,05,06 |
| Date Received | 2011-11-18 |
| Date of Report | 2011-09-25 |
| Date of Event | 2011-09-25 |
| Date Mfgr Received | 2011-09-25 |
| Device Manufacturer Date | 2011-04-22 |
| Date Added to Maude | 2011-11-21 |
| 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 | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 928216232 |
| Manufacturer Country | US |
| Manufacturer Postal | 928216232 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821623 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 6232 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT) |
| Generic Name | IMMUNOCHEMICAL, CERULOPLASMIN |
| Product Code | DEM |
| Date Received | 2011-11-18 |
| Model Number | IMMAGE AAT REAGENT |
| Catalog Number | 447740 |
| Lot Number | M105003 |
| Device Expiration Date | 2013-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821623 US 92821 6232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-18 |