FDA Adverse Event
Malfunction
Summary report: N
OLYMPUS AUTOMATED CLINICAL CHEMISTRY ANALYZER
MDR report key: 421552
·
Received October 10, 2002
Report
- Report Number
- 8010047-2002-00091
- Event Type
- Malfunction
- Date Received
- October 10, 2002
- Report Date
- October 10, 2002
- Manufacturer
- OLYMPUS OPTICAL CO., LTD., SAN-EI BUILDING
- Product Code
- JJE
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IF THE ANALYZER IS OPERATING IN A SAMPLE MEASUREMENT MODE AND THE CUSTOMER IS UTILIZING THE SEQUENTIAL (NON-BARCODED SAMPLES) SAMPLE IDENTIFICATION MODE, AND DATA IS EDITED USING THE ANALYZER SOFTWARE FEATURE, A DATABASE CONFLICT MAY OCCUR WHICH MAY RESULT IN ONE SAMPLE NUMBER BEING USED FOR TWO SEPARATE SAMPLE TEST RESULTS. THERE IS NO POTENTIAL FOR THIS EVENT IF THE ANALYZER STATUS IS STOP, PAUSE, STAND-BY, WHICH COULD RESULT IN A SAMPLE CONCORDANCE ERROR. THERE WERE NO INJURIES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OLYMPUS AUTOMATED CLINICAL CHEMISTRY ANALYZER | AUTOMATED CLINICAL CHEMISTRY ANALYZER | JJE | OLYMPUS OPTICAL CO., LTD., SAN-EI BUILDING | AU400 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |