FDA Adverse Event
Malfunction
Summary report: N
ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM
MDR report key: 1911194
·
Received November 30, 2010
Report
- Report Number
- 2122870-2010-00837
- 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
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLES WERE COLLECTED IN SERUM SEPARATOR TUBES. 19 OUT OF THE 39 SAMPLES HAD VISIBLE FIBRIN. THE CUSTOMER'S LAB HAS PROCEDURE TO REPEAT ALL PATIENT SAMPLES WITH ACCUTNI RESULTS OF > 0.05 NG/ML PRIOR TO REPORTING. 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 39 OCCURRENCES OF 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 |