MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-04-07 for IMMAGE? MICROALBUMIN (MA) REAGENT N/A 447690 manufactured by Beckman Coulter Inc..
[1885970]
A customer contacted beckman coulter inc. (bci) stating that the results of controls and patient specimens are unstable for the microalbumin reagent. The customer also stated that the microalbumin reagent generated different results when loaded on different cartridges. No sample information was provided except that sample results were different with different lots or cartridges of reagent. No affect to patients were reported, as the results were not reported out of the laboratory.
Patient Sequence No: 1, Text Type: D, B5
[9178549]
No sample information was provided. The sample type for microalbumin is usually random urine. Customer noted that qc has been unacceptable. Customer did not note any system errors or issues. It is unknown whether a new lot or cartridge of reagent resolved the issue. Service was not needed for this event, as this is a reagent issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-01041 |
| MDR Report Key | 2044583 |
| Report Source | 01,06 |
| Date Received | 2011-04-07 |
| Date of Report | 2011-03-09 |
| Date of Event | 2011-03-09 |
| Date Mfgr Received | 2011-03-09 |
| Device Manufacturer Date | 2010-10-01 |
| Date Added to Maude | 2011-05-03 |
| 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 NORA ZEROUNIAN |
| Manufacturer Street | 250 S KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER INC. |
| Manufacturer Street | 250 S. KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMAGE? MICROALBUMIN (MA) REAGENT |
| Generic Name | MICROALBUMIN (MA) REAGENT |
| Product Code | JIQ |
| Date Received | 2011-04-07 |
| Model Number | N/A |
| Catalog Number | 447690 |
| Lot Number | M010304 |
| Device Expiration Date | 2012-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER INC. |
| Manufacturer Address | 250 S. KRAEMER BOULEVARD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-07 |