LDHI2 LACTATE DEHYDROGENASE ACC. TO IFCC VER.2
Received Jan 28, 2019
Report 1823260-2019-90010 · MDR key 8281628
Device
Generic name
Lactate Dehydrogenase Test System
Manufacturer
Roche DiagnosticsModel number
LDHI G2Lot number
36247301
Product problems
- Low Test Results
- Low Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE FOLLOW UP/CORRECTIVE ACTIONS WERE THAT THE CUSTOMER CHANGED THE REAGENT CASSETTE AND THE ISSUE SEEMS TO BE RESOLVED AS THERE HAVE BEEN NO FURTHER ISSUES. PRECISION CHECK TESTING WAS PERFORMED WITH ACCEPTABLE RESULTS. NO DEVICES WERE RETURNED THIS DEVICE IS NOT LABELED FOR SINGLE USE AND IS NOT REPROCESSED OR REUSED.
Description of Event or Problem
THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. AN ERRONEOUS LOW RESULT WAS GENERATED BY THE COBAS 8000 C 702 MODULE. THE EVENT INVOLVED 1 PATIENT WITH AN ERRONEOUS RESULT FOR LDHI2 LACTATE DEHYDROGENASE ACC. TO IFCC VER.2. THE PATIENT'S AGE WAS REQUESTED BUT WAS NOT PROVIDED. THE PATIENT'S WEIGHT WAS REQUESTED BUT WAS NOT PROVIDED. THE PATIENT'S GENDER WAS REQUESTED BUT WAS NOT PROVIDED. THE PATIENT'S RACE WAS REQUESTED BUT WAS NOT PROVIDED. THE PATIENT'S ETHNICITY WAS REQUESTED BUT WAS NOT PROVIDED.