LDHI2
Received Mar 21, 2022 · Event occurred Feb 28, 2022
Report 1823260-2022-00786 · MDR key 13838949
Device
Generic name
Lactate Dehydrogenase Test System
Manufacturer
Roche DiagnosticsModel number
NACatalog number
08057958190
Lot number
58977201
Product problems
- Low Test Results
- Non Reproducible Results
- Low Test Results
- Non Reproducible Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE LOW LDHI2 LACTATE DEHYDROGENASE VER.2 RESULT FROM COBAS PRO C 503 ANALYTICAL UNIT SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 167 U/L. THE REPEAT RESULT AT ANOTHER SITE WAS 409 U/L. ON (B)(6) 2022, THE REPEAT RESULT USING REAGENT LOT NUMBER 618368 WAS 399 U/L. USING A NEW PACK FROM REAGENT LOT 589772, THE RESULT WAS 409 U/L. IT WAS REQUESTED BUT NOT KNOWN IF ANY QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.
Additional Manufacturer Narrative
THE CALIBRATION DATA PROVIDED WAS ACCEPTABLE. THE ISSUE WAS RESOLVED BY THE CUSTOMER USING A NEW REAGENT CASSETTE FROM THE SAME LOT. THE INVESTIGATION DETERMINED THE ISSUE WAS CONSISTENT WITH CONTAMINATION OR DENATURATION OF A SINGLE REAGENT CASSETTE. THE CAUSE OF THE CONTAMINATION OR DENATURATION COULD NOT BE DETERMINED WITH THE INFORMATION AVAILABLE.