LACTATE DEHYDROGENASE
Received Nov 20, 2023 · Event occurred Oct 23, 2023
Report 1823260-2023-03682 · MDR key 18170481
Device
Generic name
Lactate Dehydrogenase Assay Using Nad/nadh
Manufacturer
Roche DiagnosticsCatalog number
03004732122
Lot number
72604101
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION DETERMINED THE ISSUE WAS CONSISTENT WITH A HIGH LEUKOCYTE CONCENTRATION IN THE SAMPLES LEADING TO AN ACCUMULATION OF CELLS CLOSE TO THE PLASMA SURFACE. FALSELY HIGH RESULTS CAN OCCUR IF BLOOD CELLS OR CELL DEBRIS ARE NOT PROPERLY REMOVED IN THE PRE-ANALYTICAL SAMPLING PROCESS. THE MOST LIKELY ROOT CAUSE IS A KNOWN INTERFERENCE CAUSED BY A PRE-ANALYTICAL ISSUE. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. THERE IS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE DEVICE.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE LDHI2 LACTATE DEHYDROGENASE ACC. TO IFCC VER.2 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 6000 C501 MODULE. THIS MEDWATCH WILL COVER LDHI2. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ALP2 RESULTS. ON 23-OCT-2023, SAMPLE 1 HAD AN INITIAL LDH RESULT OF 375 U/L. TH SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 592 U/L AND 440 U/L. ON 25-OCT-2023, SAMPLE 2 HAD AN INITIAL LDH RESULT OF 598.0 U/L. THE REPEAT RESULT WAS 254.1 U/L.
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE CALIBRATION TRACE DATA PROVIDED WAS ACCEPTABLE. THE INVESTIGATION IS ONGOING.