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 2012-03-21 for IMMAGE? RHEUMATOID FACTOR REAGENT IMMAGE RF 447070 manufactured by Beckman Coulter, Inc..
[20233498]
A customer reported to beckman coulter inc. (bci) that erroneously elevated rheumatoid factor (rf) results had been generated by immage 800 immunochemistry system. Immage rheumatoid factor reagent lot m103174 was used for the assays. The customer indicated there had been too many rf results between 20 iu/ml and 25 iu/ml for the patients for whom rf results below 20 iu/ml were expected. The erroneous results were reported out of the laboratory. The customer indicated there had been no report of any change to patient treatment based on the erroneously reported results. Immage 800 immunochemistry system: catalogue number - a15445, serial number - (b)(4). Product code - jqx, nephelometer, for clinical use. The 510(k) number - k962294.
Patient Sequence No: 1, Text Type: D, B5
[20392288]
No sample information was provided. Qc results provided by the customer appear acceptable. The customer indicated issue started when they began using rf reagent lot m103174. Root cause is not known but this appears to be a reagent issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00720 |
| MDR Report Key | 2499250 |
| Report Source | 01,05,06 |
| Date Received | 2012-03-21 |
| Date of Report | 2012-02-24 |
| Date of Event | 2012-02-17 |
| Date Mfgr Received | 2012-02-24 |
| Device Manufacturer Date | 2011-10-18 |
| Date Added to Maude | 2012-08-28 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMAGE? RHEUMATOID FACTOR REAGENT |
| Generic Name | RHEUMATOID FACTOR TEST REAGENT |
| Product Code | DHR |
| Date Received | 2012-03-21 |
| Model Number | IMMAGE RF |
| Catalog Number | 447070 |
| Lot Number | M103174 |
| Device Expiration Date | 2013-08-31 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2012-03-21 |