MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-07-24 for IMMAGE? 800 IMMUNOCHEMISTRY SYSTEM A15445 manufactured by Beckman Coulter, Inc..
[2045748]
The customer contacted beckman coulter, inc. (bci) to report discrepant patient sample results and a shift in quality control results for rheumatoid factor (rf) assayed on an immage 800 immunochemistry system. The patient results were reported out of the laboratory. It is unknown if there was an impact to patient treatment due to the discrepant rf results. The customer reported discrepant rf patient results for one sample when switching from rf reagent lot # m101863 to rf reagent lot # m007630. The customer reported that quality control results shifted low and were outside of the laboratory's established range when switching to rf reagent lot # m007630. A definitive root cause has not yet been determined for this event.
Patient Sequence No: 1, Text Type: D, B5
[9247922]
Reagent lot changed. Discrepant patient results and a shift of quality control results were obtained. A definitive root cause for the event has not yet been determined. The customer initially contacted bci on (b)(6) 2011 to report the shift in quality control results for rf. The customer followed up with a subsequent communication on (b)(6) 2011 to report the discrepant patient results for rf.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-03399 |
| MDR Report Key | 2174175 |
| Report Source | 01,06 |
| Date Received | 2011-07-24 |
| Date of Report | 2011-06-09 |
| Date of Event | 2011-06-08 |
| Date Mfgr Received | 2011-06-09 |
| Date Added to Maude | 2012-04-11 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| 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? 800 IMMUNOCHEMISTRY SYSTEM |
| Generic Name | NEPHELOMETER FOR CLINICAL USE |
| Product Code | JQX |
| Date Received | 2011-07-24 |
| Catalog Number | A15445 |
| Device Availability | Y |
| 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 | 2011-07-24 |