FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM
MDR report key: 2143704
·
Received June 29, 2011
Report
- Report Number
- 2122870-2011-02079
- Event Type
- Malfunction
- Date Received
- June 29, 2011
- Date of Event
- May 30, 2011
- Report Date
- May 30, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- MMI
- PMA / PMN Number
- K023764
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO ADDITIONAL INFORMATION WAS PROVIDED FOR THIS EVENT.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ELEVATED TROPONIN (ACCUTNI) RESULTS GENERATED BY THE UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT'S SAMPLE THAT DID NOT MATCH THE CLINICAL PICTURE. REPEAT TESTING RESULTED WITHIN THE ASSAY'S PRECISION CLAIMS. ACCUTNI RESULTS DECLINED OVER THE NEXT FEW DAYS TO <0.04NG/ML. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER | MMI | BECKMAN COULTER INC. | DXI 800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |