LACTATE DEHYDROGENASE
Received Mar 13, 2023 · Event occurred Feb 20, 2023
Report 1823260-2023-00790 · MDR key 16531778
Device
Generic name
Lactate Dehydrogenase Assay Using Nad/nadh
Manufacturer
Roche DiagnosticsModel number
NACatalog number
03004732122
Lot number
ASKU
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE PROVIDED CALIBRATION AND CONTROL DATA WERE ACCEPTABLE.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH LDHI2 LACTATE DEHYDROGENASE ACC. TO IFCC VER.2 ON A COBAS INTEGRA 400 PLUS (SERIAL NUMBER (B)(4). NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER INITIALLY HAD ISSUES WITH AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH LDH. THE RESULTS WOULD BE HIGH AND THEN REPEAT LOWER. THE PROBES WERE REPLACED AND PRECISION WAS CHECKED. A WASH STATION WAS ALSO INSPECTED. THE FIELD APPLICATION SPECIALIST UPDATED THE APPLICATION SETTINGS TO USE A DIFFERENT APPLICATION OF THE SAME REAGENT, BUT THE ISSUE STILL PERSISTED LEADING TO THE COMPLAINED SAMPLE RESULTS. THE SAMPLE INITIALLY RESULTED IN AN LDH VALUE OF 733 U/L. DUE TO ONGOING ISSUES OF THE SAME NATURE, THE SAMPLE WAS REPEATED TWICE, RESULTING IN VALUES OF 211 U/L AND 217 U/L.
Additional Manufacturer Narrative
THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE ISSUE IS CONSISTENT WITH INCORRECT PRE-ANALYTIC SAMPLE HANDLING.