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..
[15195037]
Customer called on (b)(6) 2011 reporting multiple false positive rheumatoid factor (rf) results generated on the immage 800 immunochemistry system. Customer reported that a high percentage of false positives was observed when rf reagent lot m101865 was used. Customer stated that they began using rf reagent lot m101865 on (b)(6) 2011. Customer indicated that since (b)(6) 2011, they have reported out 745 rf results and 560 of them were <20 iu/ml, 129 results were between 20-30 iu/ml, 44 results were >30 iu/ml and 12 results were 20 iu/ml. Customer noted that of the 129 results which were between 20-30 iu/ml, approximately 35% were run after the new lot was loaded on (b)(6) /2011. Customer mentioned that previous rf lot m106133 did not display such a high number of positives. Customer also stated that 4 positive sample results which were questioned by a doctor had been run outside of the lab and came back normal. Customer had provided printouts for 5 different patients. Two of the patient results were believed to be sent in error as they were not erroneous. This report is for the erroneous patient result which was generated on 12/14/2011. Please see medwatch #2050012-2012-00216, 2050012-2012-00218 and 2050012-2012-00219 for the reports on the other three patients. No change to patients' treatments were initiated as a result of the erroneous results. Review of customer's instrument printouts indicated that an erroneous result of 22 iu/ml was generated on 12/14/2011. The sample was rerun on 12/15/2011 and a result of <15 iu/ml was obtained and reported out of the lab. Field service engineer was not dispatched nor requested by the customer as this appears to be a reagent related issue.
Patient Sequence No: 1, Text Type: D, B5
[15798298]
Evaluation - results - root cause is unknown but appears to be a reagent issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00217 |
| MDR Report Key | 2429549 |
| Report Source | 05,06 |
| Date Received | 2012-01-26 |
| Date of Report | 2011-12-28 |
| Date of Event | 2011-12-14 |
| Date Mfgr Received | 2011-12-28 |
| 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 BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| 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 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 | M101865 |
| Device Expiration Date | 2013-06-30 |
| 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 |