FDA Adverse Event
Malfunction
Summary report: N
VITROS DT60 SYSTEM
MDR report key: 739789
·
Received July 20, 2006
Report
- Report Number
- 1319681-2006-00161
- Event Type
- Malfunction
- Date Received
- July 20, 2006
- Date of Event
- June 26, 2006
- Report Date
- June 26, 2006
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS
- Product Code
- JJE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION INTO THIS EVENT REVEALED THAT THE BIASED QC RESULTS WERE OBTAINED FOLLOWING MULTIPLE E14 ERROR CODES (RESULTS INVALID). ELECTROMETER PERFORMANCE WAS WITHIN EXPECTED INTERVALS. THE UNIT WAS RETURNED FOR SERVICE. THE DEPOT SERVICE ENGINEER REPLACED THE SLIDE HOLD DOWN SPRINGS. POST-SERVICE CONTROL RESULTS WERE WITHIN EXPECTED INTERVALS. THE ROOT CAUSE OF THE EVENT WAS INSTRUMENT RELATED.
Description of Event or Problem · 1
A CUSTOMER OBSERVED BIASED K+QC RESULTS ON THE VITROS DT60 ANALYZER. NO PATIENT RESULTS WERE REPORTED. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITROS DT60 SYSTEM | CLINICAL CHEMISTRY ANALYZER | JJE | ORTHO-CLINICAL DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |