MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-02-16 for IMMAGE? RHEUMATOID FACTOR REAGENT 447070 manufactured by Beckman Coulter, Inc..
[2436647]
The customer contacted beckman coulter, inc. (bec) to report erroneous results for rheumatoid factor (rf) for fifteen (15) patient samples assayed with rheumatoid factor reagent on an immage immunochemistry system. The erroneous rf results were reported outside of the laboratory and were questioned by the ordering physicians. There was no impact to patient treatment associated with this event. The customer reported that the erroneous rf results were obtained using rf reagent lot #m012376. The customer reported that quality control results were recovering within the laboratory's established ranges both prior to and after the event. The customer reported performing repeat rf analyses on the patient samples using a different lot of rf reagent (lot #m106133). The repeat rf analyses yielded lower rf results for all fifteen (15) patient samples. Amended reports were generated and reported outside of the laboratory.
Patient Sequence No: 1, Text Type: D, B5
[9718147]
The performance of the rf reagent is currently being investigated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00437 |
| MDR Report Key | 2457749 |
| Report Source | 05,06 |
| Date Received | 2012-02-16 |
| Date of Report | 2012-01-17 |
| Date of Event | 2012-01-17 |
| Date Mfgr Received | 2012-01-17 |
| Device Manufacturer Date | 2011-03-31 |
| Date Added to Maude | 2012-08-17 |
| 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 BLVD. |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMAGE? RHEUMATOID FACTOR REAGENT |
| Generic Name | RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM |
| Product Code | DHR |
| Date Received | 2012-02-16 |
| Model Number | NA |
| Catalog Number | 447070 |
| Lot Number | M012376 |
| ID Number | NA |
| Device Expiration Date | 2013-03-31 |
| 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 | 2012-02-16 |