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 2012-02-09 for IMMAGE? RHEUMATOID FACTOR REAGENT IMMAGE RF 447070 manufactured by Beckman Coulter, Inc..
[16925232]
The customer reported false positive rheumatoid factor (rf) results were generated on the immage rheumatoid factor reagent lot m012376 which used on immage immunochemistry system. The customer stated that the number of rf high results have increased since the use of rf reagent lot m012376. The customer also stated that qc results have increased. The results were not reported out of the laboratory; hence patient treatment was not impacted by this event. The customer recalibrated the instrument, however, the issue remained. The instrument is currently performing within qc specifications with respect to controls (accuracy) and reproducibility (precision).
Patient Sequence No: 1, Text Type: D, B5
[17044517]
Root cause is not known but this appears to be a reagent related issue. The customer was sent a replacement lot of reagent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00452 |
| MDR Report Key | 2445149 |
| Report Source | 01,05,06 |
| Date Received | 2012-02-09 |
| Date of Report | 2012-01-19 |
| Date of Event | 2012-01-16 |
| Date Mfgr Received | 2012-01-19 |
| Device Manufacturer Date | 2011-03-31 |
| Date Added to Maude | 2012-08-15 |
| 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 | MRS. 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 | 2470 FARADAY AVE. |
| Manufacturer City | CARLSBAD CA 92010 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 2050012-01/26/2012-003C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMAGE? RHEUMATOID FACTOR REAGENT |
| Generic Name | SYSTEM, TEST, RHEUMATOID FACTOR |
| Product Code | DHR |
| Date Received | 2012-02-09 |
| Model Number | IMMAGE RF |
| Catalog Number | 447070 |
| Lot Number | M012376 |
| ID Number | N/A |
| Device Expiration Date | 2013-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 2012-02-09 |