FDA Adverse Event
Malfunction
Summary report: N
ACCESS 2 IMMUNOASSAY SYSTEM
MDR report key: 1932221
·
Received December 17, 2010
Report
- Report Number
- 2122870-2010-00898
- Event Type
- Malfunction
- Date Received
- December 17, 2010
- Date of Event
- November 17, 2010
- Report Date
- November 18, 2010
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- MMI
- PMA / PMN Number
- 922823/A007
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLES WERE IN LITHIUM PLASMA WHICH WERE CENTRIFUGED FOR >5 MINUTES AT <5000RPM. QC WAS WITHIN SPECIFICATIONS DURING THE EVENT. SERVICE WAS NOT DISPATCHED THE SAMPLE WAS SENT TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR FURTHER TESTING. CPLS WAS UNABLE TO CONFIRM AN INTERFERENT IN THE PATIENT'S SAMPLE. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO REPRODUCIBLE ELEVATED ACCUTNI RESULTS ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUT-OFF GENERATED BY ACCESS 2 IMMUNOASSAY ANALYZER, WHICH DID NOT MATCH THE PATIENT'S CLINICAL PICTURE. UNKNOWN IF PATIENT TREATMENT WAS WITHHELD OR ADMINISTERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCESS 2 IMMUNOASSAY SYSTEM | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER | MMI | BECKMAN COULTER INC. | ACCESS 2 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |