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 2012-02-16 for IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT IMMAGE RF REAGENT 447070 manufactured by Beckman Coulter, Inc..
[2722242]
This follow up report is being submitted to correct an error in the original report. Correction: the erroneous results were reported out of the laboratory; however, patient treatment was not affected.
Patient Sequence No: 1, Text Type: D, B5
[9912741]
This is a follow up report.
Patient Sequence No: 1, Text Type: N, H10
[14887166]
Customer called to report that the immage immunochemistry system generated falsely positive rheumatoid factor (rf) patient results when the immage system rheumatoid factor (rf) reagent, lot #m008778, was used. Customer stated that the results were not reported outside the laboratory; therefore, patient treatment was not affected. The positive rf results did not correlate with the patients' physical examinations. The patient samples were then re-run with a different rf reagent lot, lot #m106133, the results of which were negative and correct. The issue appears to be related to the reagent lot that was initially used, and not the instrument. Customer was provided with a replacement reagent lot.
Patient Sequence No: 1, Text Type: D, B5
[15274658]
The root cause of the issue appears to be reagent-specific as the issue was resolved after customer used another reagent lot, as described in section b5. Please note that two additional medical device reports were submitted based on the same set of events as mdr #2050012-2012-00507 (b)(4) for rf results that were generated on (b)(6) 2011 and (b)(6) 2012, respectively. (b)(4). Other text : reagent was not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00508 |
| MDR Report Key | 2454956 |
| Report Source | 01,05,06 |
| Date Received | 2012-02-16 |
| Date of Report | 2012-01-17 |
| Date of Event | 2011-12-30 |
| Date Mfgr Received | 2012-05-15 |
| Device Manufacturer Date | 2010-12-16 |
| 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 BLVD. |
| Manufacturer City | BREA CA 928216232 |
| Manufacturer Country | US |
| Manufacturer Postal | 928216232 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821623 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 6232 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT |
| Generic Name | SYSTEM, TEST, RHEUMATOID FACTOR |
| Product Code | DHR |
| Date Received | 2012-02-16 |
| Model Number | IMMAGE RF REAGENT |
| Catalog Number | 447070 |
| Lot Number | M008778 |
| Device Expiration Date | 2012-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 92821623 US 92821 6232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-16 |