FDA Adverse Event
Malfunction
Summary report: N
OLYMPUS AUTOMATED CLINICAL CHEMISTRY ANALYZER
MDR report key: 420033
·
Received October 1, 2002
Report
- Report Number
- 8010047-2002-00085
- Event Type
- Malfunction
- Date Received
- October 1, 2002
- Report Date
- October 1, 2002
- Manufacturer
- OLYMPUS OPTICAL CO., LTD.
- Product Code
- JJE
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
FOREIGN CUSTOMER REPORT OF ANALYZER MALFUNCTION DURING OPERATION. IF LIH (LIPEMIA, ICTERUS, HEMOLYSIS) TESTING IS SWITCHED FROM USE OF A DEDICATED SALINE REAGNET TO THE USE OF AN EXISTING R1 CHEMISTRY REAGENT FOR LIH TESTING, THEN THE ANALYZER WILL CONDUCT A CHEMISTRY TEST CORRESPONDING TO THE ORDINAL PLACEMENT OF THE LIH TEST REQUISITION USING THE TEST PARAMETERS PROGRAMMED FOR A DIFFERENT CHEMISTRY TEST ASSAY; POTENTIALLY RESULTING IN ERRONEOUS RESULTS. THERE IS NO POTENTIAL FOR THIS EVENT IF THE USE OF A DEDICATED REAGENT FOR LIH TESTING IS CONTINUOUSLY USED. THERE HAVE BEEN NO REPORTS OF THIS SITUATION OCCURRING IN THE UNITED STATES, AND THERE WERE NO INJURIES REPORTED BY THE FOREIGN REPORTER.
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. | AU400 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |