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 2012-02-06 for IMMAGE IMMUNOCHEMISTRY SYSTEM RHEUMATOID FACTOR (RF) REAGENT 475136 manufactured by Beckman Coulter Inc..
[2534102]
A customer contacted beckman coulter inc. (bec) regarding false positive rf results generated by the immage 800 system using rf lot m101865. The erroneous results were not reported outside of the laboratory and there was no affect to patients with regard to this event.
Patient Sequence No: 1, Text Type: D, B5
[9617067]
The root cause for this event appeared to be related to the reagent lot. The customer was sent a replacement.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00427 |
| MDR Report Key | 2440266 |
| Report Source | 01,05,06 |
| Date Received | 2012-02-06 |
| Date of Report | 2012-01-19 |
| Date of Event | 2012-01-19 |
| Date Mfgr Received | 2012-01-19 |
| Device Manufacturer Date | 2011-08-04 |
| Date Added to Maude | 2012-08-14 |
| 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 BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER INC. |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | 2050012-01/26/2012-003C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMAGE IMMUNOCHEMISTRY SYSTEM RHEUMATOID FACTOR (RF) REAGENT |
| Generic Name | RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM |
| Product Code | DHR |
| Date Received | 2012-02-06 |
| Model Number | NA |
| Catalog Number | 475136 |
| Lot Number | M101865 |
| Device Expiration Date | 2013-06-30 |
| 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 BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-06 |