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 2012-01-26 for IMMAGE? RHEUMATOID FACTOR (RF REAGENT) 447070 manufactured by Beckman Coulter Inc..
[16737776]
A customer contacted beckman coulter inc. (bec) in regards to obtaining false positive immage rheumatoid factor (rf) results that were generated on the immage 800 immunochemistry system over four (4) consecutive days ((b)(6) 2011). Over this time, the customer used one (1) immage (rf) reagent lot (lot # m101865) in conjunction to the immage 800 instrument. This report documents the results generated on (b)(6) 2011. No confirmatory testing results were provided. Results which are >20 iu/ml are considered positive for rf. It is assumed that the results that are >20 iu/ml but <30 iu/ml falsely positive. Results over 30 are not being questioned. The normal reference range for rf ranges from 0 - 20 iu/ml. No erroneous results were reported out of the laboratory. Patient treatment was not affected by this event.
Patient Sequence No: 1, Text Type: D, B5
[17042604]
No sample information was provided by the customer. Per the customer complaint record, no sample issues were noted and controls are running acceptably. The customer was sent a new rf reagent lot and no further issues were reported. Service was not requested by the customer, as this event appears to be a reagent issue. This report is related to the following mdrs that are being reported on different dates for the similar event that occurred at this customer site: 2050012-2012-00290, 2050012-2012-00292, 2050012-2012-00294.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00293 |
| MDR Report Key | 2429843 |
| Report Source | 01,05,06 |
| Date Received | 2012-01-26 |
| Date of Report | 2011-12-27 |
| Date of Event | 2011-12-22 |
| Date Mfgr Received | 2011-12-27 |
| Device Manufacturer Date | 2011-08-04 |
| Date Added to Maude | 2012-08-09 |
| 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 BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMAGE? RHEUMATOID FACTOR (RF REAGENT) |
| Generic Name | SYSTEM, TEST, RHEUMATOID FACTOR |
| Product Code | DHR |
| Date Received | 2012-01-26 |
| Model Number | RF REAGENT |
| Catalog Number | 447070 |
| Lot Number | M101865 |
| Device Expiration Date | 2013-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2012-01-26 |