MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-01-05 for MICROALBUMIN OSR6167 manufactured by Beckman Coulter Biomedical Limited.
[1719771]
A customer contacted beckman coulter inc. (bci) in regards to erroneous microalbumin results generated on au5400 chemistry analyzer for two patients. The results were not reported out of the laboratory. Subsequent testing produced lower results. There was no effect to the patients or user.
Patient Sequence No: 1, Text Type: D, B5
[8814765]
The presence of drugs may have interfered with the microalbumin tests, and produced excessively high results with flags. The system was configured in such a way that the flags triggered an automatic rerun with a 1/10 dilution. This dilution may have reduced the background absorbance to tolerable levels, but also diluted the urine albumin concentration below the bottom of the dynamic range, giving results with g flags which were then multiplied by the dilution ratio (10) to give a final result apparently inside the measuring range (5 - 300 mg/l). The samples are not available for further investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-00001 |
| MDR Report Key | 1949859 |
| Report Source | 05 |
| Date Received | 2011-01-05 |
| Date of Report | 2010-12-07 |
| Date of Event | 2010-12-07 |
| Date Mfgr Received | 2010-12-07 |
| Date Added to Maude | 2011-05-04 |
| 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 BIOMEDICAL LIMITED |
| Manufacturer Street | LISMEEHAN O'CALLAGHAN'S MILLS |
| Manufacturer City | CO. CLARE, |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROALBUMIN |
| Generic Name | MICROALBUMIN TEST |
| Product Code | JIR |
| Date Received | 2011-01-05 |
| Model Number | NA |
| Catalog Number | OSR6167 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER BIOMEDICAL LIMITED |
| Manufacturer Address | LISMEEHAN O'CALLAGHAN'S MILLS CO. CLARE, EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-05 |