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 2012-02-14 for RHEUMATOID FACTOR REAGENT 447070 manufactured by Beckman Coulter, Inc..
[2435012]
Customer reported to beckman coulter, inc. (bec) that false positive rheumatoid factor (rf) patient results were generated when rheumatoid factor reagent lot number m008778 was used on the immage immunochemistry system. Customer reported that negative results were obtained when the tests were re-run with a different lot of rf reagent. Customer reported that erroneous 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
[2722240]
This follow up report is being submitted to correct an error in the original report. Correction: the erroneous results were reported out of the laboratory; however, patient treatment was not affected.
Patient Sequence No: 1, Text Type: D, B5
[9635375]
Erroneous rheumatoid factor results were generated on four different days. This report is one of four reports related to four events that occurred on four different days. This report is related to mdr#2050010-2012-00001, 2050010-2012-00003, 2050010-2012-00004.
Patient Sequence No: 1, Text Type: N, H10
[9906201]
This is a follow up report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050010-2012-00002 |
| MDR Report Key | 2451792 |
| Report Source | 01,05,06 |
| Date Received | 2012-02-14 |
| Date of Report | 2012-01-17 |
| Date of Event | 2011-12-30 |
| Date Mfgr Received | 2012-05-15 |
| Device Manufacturer Date | 2010-12-16 |
| Date Added to Maude | 2012-08-16 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RHEUMATOID FACTOR REAGENT |
| Generic Name | SYSTEM, TEST, RHEUMATOID FACTOR |
| Product Code | DHR |
| Date Received | 2012-02-14 |
| Catalog Number | 447070 |
| Lot Number | M008778 |
| Device Expiration Date | 2012-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2012-02-14 |