FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 600I ACCESS® 2 IMMUNOASSAY SYSTEM
MDR report key: 1964376
·
Received January 19, 2011
Report
- Report Number
- 2122870-2011-00073
- Event Type
- Malfunction
- Date Received
- January 19, 2011
- Date of Event
- December 21, 2010
- Report Date
- December 21, 2010
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- MMI
- PMA / PMN Number
- K060256
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER INDICATED THAT A PROACTIVE PROCEDURE HAS BEEN IMPLEMENTED TO VERIFY UNEXPECTED RESULTS PRIOR TO REPORTING THE RESULTS OUTSIDE THE LABORATORY THEREBY PREVENTING POTENTIAL RISK TO PATIENT SAFETY. THE PROCEDURE IS TO REPEAT ALL SAMPLES WITH THE RESULTS GREATER THAN 0.4 NG/ML. THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN THE QC SPECIFICATIONS. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. A ROOT CAUSE FOR THIS EVENT WAS NOT DETERMINED.
Description of Event or Problem · 1
A CUSTOMER WAS CONTACTED BY BECKMAN COULTER INC (BCI) VIA ACCUTNI CUSTOMER CONTACT PROGRAM AND INDICATED A RECENT OCCURRENCE OF NON-REPRODUCIBLE FALSE POSITIVE TROPONIN (ACCUTNI) RESULTS. THE CUSTOMER DID NOT REPORT EFFECT TO PATIENT OR USER ATTRIBUTED OR CONNECTED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 600I ACCESS® 2 IMMUNOASSAY SYSTEM | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER | MMI | BECKMAN COULTER, INC. | DXC 600I | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |