MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-03-22 for URINARY/CSF PROTEIN OSR6170 manufactured by Beckman Coulter Biomedical Ireland Limited.
[1290308]
A customer contacted beckman coulter inc. (bci) regarding negative results for urine protein patient samples generated on au chemistry system using urinary/csf protein reagent. The results were reported out of the lab. Unknown if patient treatment was affected in connection with this event.
Patient Sequence No: 1, Text Type: D, B5
[8445057]
Calibration and qc were recovering with specifications. The specimen type was urine. Patient samples were requested from the customer and tested in house on the au 640 instrument and on a different analyzer. The au 640 analyzer generated negative results (except for one sample), and the different instrument gave "oir lo" results for all samples. Although reaction monitor data is consistent with an interference, a clear root cause for this event has not been determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2010-00125 |
| MDR Report Key | 1636886 |
| Report Source | 05 |
| Date Received | 2010-03-22 |
| Date of Report | 2010-03-22 |
| Date of Event | 2010-02-22 |
| Date Mfgr Received | 2010-02-23 |
| Date Added to Maude | 2010-08-10 |
| 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 BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER BIOMEDICAL IRELAND LIMITED |
| Manufacturer Street | LISMEEHAN, O'CALLAGHANS MILLS COUNTY CLARE |
| Manufacturer City | COUNTY CLARE, |
| Manufacturer Country | EI |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | URINARY/CSF PROTEIN |
| Generic Name | URINARY/CFS PROTEIN |
| Product Code | JGQ |
| Date Received | 2010-03-22 |
| Catalog Number | OSR6170 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER BIOMEDICAL IRELAND LIMITED |
| Manufacturer Address | LISMEEHAN, O'CALLAGHANS MILLS COUNTY CLAIRE, EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-03-22 |