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 2012-02-22 for RHEUMATOID FACTOR REAGENT 447070 manufactured by Beckman Coulter, Inc..
[2522385]
Customer reported to beckman coulter, inc. (bec) that the percentage of positive rheumatoid factor (rf) results increased after using rf reagent lot m012376. Customer reported that the results were always a little over 20 iu/ml. Customer reported that the results were generated by the immage immunochemistry system. Customer reported that the false positive rf results were not reported out of the laboratory. There was no report of any adverse event or injury requiring medical intervention or patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[9713663]
This report is one of three reports related to three events that occurred on the same day. This report is related to mdr #2050010-2012-00009, 2050010-2012-00011.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050010-2012-00010 |
| MDR Report Key | 2464774 |
| Report Source | 01,05,06 |
| Date Received | 2012-02-22 |
| Date of Report | 2011-12-15 |
| Date of Event | 2011-12-11 |
| Date Mfgr Received | 2011-12-15 |
| Device Manufacturer Date | 2011-03-31 |
| Date Added to Maude | 2012-08-22 |
| 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. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 2470 FARADAY AVENUE |
| Manufacturer City | CARLSBAD CA 92010 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92010 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | 2050012-01/26/2012-003C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RHEUMATOID FACTOR REAGENT |
| Generic Name | SYSTEM, TEST, RHEUMATOID FACTOR |
| Product Code | DHR |
| Date Received | 2012-02-22 |
| Catalog Number | 447070 |
| Lot Number | M012376 |
| Device Expiration Date | 2013-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 2470 FARADAY AVENUE CARLSBAD CA 92010 US 92010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-22 |