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 2011-06-10 for IMMAGE IMMUNOCHEMISTRY SYSTEM 470000 manufactured by Beckman Coulter Inc..
[2054150]
A customer reported to beckman coulter inc. (bci) that the immage immunochemistry system generated erratic microalbumin (ma) results for seven (7) patients. No specific patient information was provided. Customer provided patient results with no specific dates. No effect on patient treatment as incorrect results have not been reported out of the laboratory.
Patient Sequence No: 1, Text Type: D, B5
[8986298]
Sample type for this assay was random urine. No sample issues were noted. Customer indicated that other chemistries were performing acceptably. Bci service performed repairs which have resolved issue. A root cause has not been determined for this event to date.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-02171 |
| MDR Report Key | 2120650 |
| Report Source | 01,05,06 |
| Date Received | 2011-06-10 |
| Date of Report | 2011-05-12 |
| Date of Event | 2011-05-12 |
| Date Mfgr Received | 2011-05-12 |
| Device Manufacturer Date | 1997-07-02 |
| Date Added to Maude | 2012-02-22 |
| 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 | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMAGE IMMUNOCHEMISTRY SYSTEM |
| Generic Name | CLINICAL IMMUNOCHEMISTRY ANALYZER |
| Product Code | JQX |
| Date Received | 2011-06-10 |
| Model Number | NA |
| Catalog Number | 470000 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2011-06-10 |