MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-01-26 for IMMAGE IMMUNOCHEMISTRY SYSTEM RHEUMATOID FACTOR (RF) REAGENT RF REAGENT 447070 manufactured by Beckman Coulter Inc..
[2556192]
Customer called on (b)(6) 2012 reporting of false positive rheumatoid factor (rf) results which were generated over a period of a few days on their immage 800 immunochemistry system but not reported outside the lab. Customer stated that she was seeing an increase in the number of false positive rf patient results when using rf reagent lot # m103174. Customer stated that more than 10% of the patients were recovering above 20 iu/ml and on repeat the results were less than 20 iu/ml. Customer indicated that the controls were in range before and after the incident. Customer reported that they were using rf reagent lot # m103174, cal-5 plus lot # m101436, buff-2 lot # m010306 and dil-1 lot # t010145. Customer also indicated that recalibrating rf with the same lot# of reagent did not resolve the issue. Customer had requested a replacement cal-5 plus lot number and was sent a new lot # m106396. Upon review of the instrument printouts provided by the customer, it was noted that the erroneous results were generated on three different days for four different patients. This report is for the erroneous results which were generated on (b)(6) 2011. Please see medwatch #2050012-2012-00227 and #2050012-2012-00260 for the report on the other two patients. Customer printouts indicated that on (b)(6) 2011, two erroneous patient results of 20. 6 iu/ml and 25. 5 iu/ml were generated. Upon rerun on the same instrument later that day, results of <20 iu/ml for both patient samples were obtained. The erroneous results were not reported out of the lab and there was no change to patient treatment attributed to the event. Customer did not report any issues with other chemistries or system errors. Root cause is not known but this appears to be a reagent related issue.
Patient Sequence No: 1, Text Type: D, B5
[9588485]
Evaluation results: root cause is unknown but appears to be a reagent issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00259 |
| MDR Report Key | 2429590 |
| Report Source | 05,06 |
| Date Received | 2012-01-26 |
| Date of Report | 2012-01-06 |
| Date of Event | 2011-12-29 |
| Date Mfgr Received | 2012-01-06 |
| Device Manufacturer Date | 2011-10-18 |
| 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 BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| 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 | 2012-01-26 |
| Model Number | RF REAGENT |
| Catalog Number | 447070 |
| Lot Number | M103174 |
| Device Expiration Date | 2013-08-31 |
| 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 | 2012-01-26 |