LDL-CHOLESTEROL GEN.3
Received Aug 14, 2025 · Event occurred Jul 24, 2025
Report 1823260-2025-02487 · MDR key 22805848
Device
Generic name
System, Test, Low Density, Lipoprotein
Manufacturer
Roche DiagnosticsCatalog number
07005717190
Lot number
ASKU
Product problems
- Chemical Problem
- Non Reproducible Results
- Chemical Problem
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE LDL-CHOLESTEROL GEN.3 RESULTS FOR ONE PATIENT SAMPLE TESTED ON A COBAS 8000 COBAS C 502 MODULE WHEN COMPARED TO THE BECKMAN COULTER AU5800 MODULE. THE INITIAL RESULT ON THE C 502 WAS 0.95 MMOL/L. THE REPEAT RESULT ON THE AU5800 WAS 2.92 MMOL/L.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE ANALYZER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE CUSTOMER INDICATED THAT CALIBRATION AND QUALITY CONTROL OVER TIME WERE WITHIN THE EXPECTED RANGE. THE INVESTIGATION DETERMINED THE ISSUE WAS LIKELY DUE TO THE PRESENCE OF A BIOLOGICAL INTERFERENCE OF THE ANALYTE. PER THE METHOD SHEET, "ABNORMAL LIVER FUNCTION AFFECTS LIPID METABOLISM; CONSEQUENTLY HDL AND LDL RESULTS ARE OF LIMITED DIAGNOSTIC VALUE. IN SOME PATIENTS WITH ABNORMAL LIVER FUNCTION, THE LDL-CHOLESTEROL RESULT IS SIGNIFICANTLY NEGATIVELY BIASED VERSUS BETA QUANTIFICATION RESULT." NO PRODUCT PROBLEM WAS IDENTIFIED.