FDA Adverse Event
Malfunction
Summary report: N
ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM
MDR report key: 1911192
·
Received November 30, 2010
Report
- Report Number
- 2122870-2010-00835
- Event Type
- Malfunction
- Date Received
- November 30, 2010
- Date of Event
- November 2, 2010
- Report Date
- November 2, 2010
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- MMI
- PMA / PMN Number
- K922823/A007
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLES WERE COLLECTED IN LITHIUM HEPARIN TUBES WITH GEL. THE CUSTOMER'S LAB HAS PROCEDURE TO REPEAT ALL PATIENT SAMPLES WITH INITIAL ACCUTNI RESULTS OF > 0.49 NG/ML. THE SAMPLES ARE RE-SPUN PRIOR TO THE RETESTS. THE ANALYZER IS CURRENTLY PERFORMING WITHIN THE QC SPECIFICATIONS. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. A ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO NON-REPRODUCIBLE FALSE POSITIVE TROPONIN (ACCUTNI) RESULTS GENERATED BY ACCESS 2 IMMUNOASSAY SYSTEM. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT REPORT EFFECT TO THE PATIENTS OR USER ATTRIBUTED OR CONNECTED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER | MMI | BECKMAN COULTER, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |