MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-02-03 for IMMAGE RHEUMATOID FACTOR (RF) IMMAGE RF 447070 manufactured by Beckman Coulter, Inc..
[2561562]
Customer reported erroneous high test results were obtained when using the immage rheumatoid factor (rf) on the immage immunochemistry system. Customer reported an increase in the number of rf positive patient results, with most of the results recovering a value slightly above 20 iu/ml. The customer recalibrated with the same lot number of reagent and test results were unchanged. Quality control was within range before and after the event. The erroneous high test results were reported out of the laboratory for approximately 60 - 80 patients. Amended reports were issued. There were no reports of death, serious injury or affect to patient management associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[9619312]
This issue is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00327 |
| MDR Report Key | 2438314 |
| Report Source | 05,06 |
| Date Received | 2012-02-03 |
| Date of Report | 2012-01-11 |
| Date of Event | 2012-01-11 |
| Date Mfgr Received | 2012-01-11 |
| Device Manufacturer Date | 2011-08-04 |
| Date Added to Maude | 2012-08-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 (RF) |
| Generic Name | SYSTEM, TEST, RHEUMATOID FACTOR |
| Product Code | DHR |
| Date Received | 2012-02-03 |
| Model Number | IMMAGE RF |
| Catalog Number | 447070 |
| Lot Number | M101865 |
| ID Number | NA |
| Device Expiration Date | 2013-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2012-02-03 |