MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-02-16 for IMMAGE IMMUNOCHEMISTRY SYSTEM RHEUMATOID FACTOR (RF) REAGENT 447070 manufactured by Beckman Coulter Inc..
[2537682]
Customer called on (b)(4) 2012, reporting of false positive (>20 iu/ml) immage immunochemistry system rheumatoid factor (rf) reagent results generated on the immage 800 immunochemistry system. Customer stated that rf reagent lot m106133 was the cause of the false positive results and rerunning the sample will usually give the correct results. Customer noted this has been a problem on and off since early december when they first started using lot m106133 and believes that the issue is with the reagent and not the instrument. Customer stated that no erroneous results have been reported outside the lab and therefore no change to patient treatment was attributed to this event. Customer did not provide any patient test results or information related to this event. No service was generated or requested for this event as customer believes that this was a reagent related issue.
Patient Sequence No: 1, Text Type: D, B5
[9714773]
Evaluation code - results code - (other): root cause is unknown but appears to be a reagent issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00494 |
| MDR Report Key | 2457082 |
| Report Source | 05,06 |
| Date Received | 2012-02-16 |
| Date of Report | 2012-01-31 |
| Date of Event | 2012-01-31 |
| Date Mfgr Received | 2012-01-31 |
| Device Manufacturer Date | 2011-07-19 |
| Date Added to Maude | 2012-08-17 |
| 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 BLVD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMAGE IMMUNOCHEMISTRY SYSTEM RHEUMATOID FACTOR (RF) REAGENT |
| Generic Name | SYSTEM, TEST, RHEUMATOID FACTOR |
| Product Code | DHR |
| Date Received | 2012-02-16 |
| Catalog Number | 447070 |
| Lot Number | M106133 |
| Device Expiration Date | 2013-07-31 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2012-02-16 |