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 2012-02-01 for IMMAGE? RHEUMATOID FACTOR REAGENT IMMAGE RF 447070 manufactured by Beckman Coulter, Inc..
[15858391]
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 m101865 was used for the assays. Rf results greater than 20 iu/ml are considered positive. It is assumed that the results between 20 and 30 iu/ml are falsely positive. Rf results over 30 are not being questioned. The customer indicated there had been too many rf results just above 20 iu/ml and too few below 20 iu/ml. The erroneous results were reported out of the laboratory. There was no change to patient treatment. Immage immunochemistry system, refurbished: catalogue number - a95121, serial number - unknown, nephelometer, for clinical use, 510(k) number - k962294.
Patient Sequence No: 1, Text Type: D, B5
[15945382]
No sample information was provided, and no sample issues were noted. No information about controls, other chemistries or system errors was provided. Root cause is not known but this appears to be a reagent issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00305 |
| MDR Report Key | 2435553 |
| Report Source | 01,05,06 |
| Date Received | 2012-02-01 |
| Date of Report | 2012-01-06 |
| Date of Event | 2012-01-06 |
| Date Mfgr Received | 2011-01-06 |
| Device Manufacturer Date | 2011-08-04 |
| Date Added to Maude | 2012-08-10 |
| 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 |
| Remedial Action | RL |
| 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 | RHEUMATOID FACTOR TEST REAGENT |
| Product Code | DHR |
| Date Received | 2012-02-01 |
| Model Number | IMMAGE RF |
| Catalog Number | 447070 |
| Lot Number | M101865 |
| Device Expiration Date | 2013-06-30 |
| 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 | 2012-02-01 |