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 IMMUNOCHEMISTRY SYSTEM RHEUMATOID (RF) REAGANT 447070 manufactured by Beckman Coulter, Inc..
[18178502]
The customer reported false positive rheumatoid factor (rf) patient results with the use of a specific immage immunochemistry system rheumatoid factor (rf) reagent lot on an immage immunochemistry system. The customer reran the samples using a different rf reagent lot and obtained lower, negative rf results. The number of patients involved in this event is unknown. The customer did not provide actual patient results. The erroneous results were not reported out of the laboratory and hence there were no reports of death, serious injury or change to patient treatment associated or attributed to this event. There were no reports of any issues with other chemistries or system errors. The samples were fresh, serum samples which were centrifuged prior to testing. No sample issues were noted. Instrument chemistry quality control results shifted high during the timeframe of the event. No patient information or additional system performance information was provided by the customer.
Patient Sequence No: 1, Text Type: D, B5
[18521820]
Service was not dispatched for this incident as the issue is believed to be reagent related.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00240 |
| MDR Report Key | 2432360 |
| Report Source | 01,05,06 |
| Date Received | 2012-01-30 |
| Date of Report | 2012-01-04 |
| Date of Event | 2012-01-03 |
| Date Mfgr Received | 2012-01-04 |
| Device Manufacturer Date | 2010-12-16 |
| 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 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMAGE IMMUNOCHEMISTRY SYSTEM RHEUMATOID (RF) REAGANT |
| Generic Name | SYSTEM, TEST, RHEUMATOID FACTOR |
| Product Code | DHR |
| Date Received | 2012-01-30 |
| Model Number | NA |
| Catalog Number | 447070 |
| Lot Number | M008778 |
| ID Number | NA |
| Device Expiration Date | 2012-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 |