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 2012-01-10 for IMMAGE IMMUNOCHEMISTRY SYSTEM A15445 manufactured by Beckman Coulter, Inc..
[9531993]
(b)(4). In the original report indicated that the device was not available for evaluation. This has been corrected to "yes" in this report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[16925177]
The customer reported that false positive rheumatoid factor (rf) patient results, associated with the use of a specific immage immunochemistry system rheumatoid factor (rf) reagent lot, were generated on an immage immunochemistry systems. Immage immunochemistry system rheumatoid factor (rf) reagent lot (b)(4) was in use on this instrument at the time of the event. Beckman coulter inc. Assessment of customer supplied data revealed the generation of eight positive rf patient results on (b)(6) 2011, which, upon repeat on the same instrument using the same rf reagent lot, generated negative results in three instances. The customer indicated that none of the associated patients' clinical examinations correlated with positive rf results. It is unknown as to why the patient results provided were generated after the date of contact for this event. The erroneous rf results were reported out of the laboratory however there were no reports of deaths, serious injuries or change to patient treatment associated or attributed to this event. No issues with other chemistries or system errors were reported. No sample issues were noted. No additional sample handling/collection information was provided by the customer.
Patient Sequence No: 1, Text Type: D, B5
[16936710]
The initial reports address was recorded in (b)(6) and could not be recorded as the characters were not accepted by the esubmitter software. Service was not dispatched for this incident. Root cause is not known but this appears to be a reagent issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00044 |
| MDR Report Key | 2408895 |
| Report Source | 01,05,06 |
| Date Received | 2012-01-10 |
| Date of Report | 2011-12-14 |
| Date of Event | 2011-12-14 |
| Date Mfgr Received | 2011-12-14 |
| Device Manufacturer Date | 2007-05-17 |
| Date Added to Maude | 2012-06-11 |
| 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 |
| Generic Name | EPHELOMETER, FOR CLINICAL USE |
| Product Code | JQX |
| Date Received | 2012-01-10 |
| Model Number | NA |
| Catalog Number | A15445 |
| Lot Number | 8475 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-10 |