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 2012-01-30 for IMMAGE? RHEUMATOID FACTOR REAGENT IMMAGE RF 447070 manufactured by Beckman Coulter, Inc..
[2512014]
A customer reported to beckman coulter inc. (bci) that erroneously elevated rheumatoid factor (rf) results were generated by immage 800 immunochemistry system on (b)(6) 2011 and (b)(6) 2011 for eight (8) patient samples. Immage rheumatoid factor reagent lot m101865 was used for the assays. The erroneous results were not reported out of the laboratory. The patients' samples produced negative results with the previous lot of rf reagent. There was no change to patient treatment. This report documents the event occurred on (b)(6) 2011. The event on (b)(6) 2011 is documented in mdr #2050012-2012-00288. Immage 800 immunochemistry system: catalogue number - a15445, serial number - (b)(4), date of manufacture - 04/03/2009, product code - nephelometer, for clinical use, 510(k) number - k962294.
Patient Sequence No: 1, Text Type: D, B5
[2516298]
The erroneous results were reported out of the laboratory, but there was no change to patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[9617219]
.
Patient Sequence No: 1, Text Type: N, H10
[9618603]
No sample issues were noted. The customer provided qc data, which appear acceptable. The customer has not reported any issues with other chemistries or any system errors. Rf reagents of different lot number were sent to the customer. Root cause is not known but this appears to be a reagent issue. Root cause investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00289 |
| MDR Report Key | 2430965 |
| Report Source | 01,05,06 |
| Date Received | 2012-01-30 |
| Date of Report | 2011-12-30 |
| Date of Event | 2011-12-07 |
| Date Mfgr Received | 2012-01-30 |
| 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 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 | NO |
| 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 | 2012-01-30 |
| Model Number | IMMAGE RF |
| Catalog Number | 447070 |
| Lot Number | M101865 |
| Device Expiration Date | 2013-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| 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 | 2012-01-30 |