LDLC3
Received Oct 24, 2023 · Event occurred Oct 2, 2023
Report 1823260-2023-03419 · MDR key 17998131
Device
Generic name
System, Test, Low Density, Lipoprotein
Manufacturer
Roche DiagnosticsCatalog number
08057966190
Lot number
ASKU
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO FURTHER DATA WAS PROVIDED BY THE CUSTOMER. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR LDLC3 ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 19.4 MG/DL. THE SAMPLE WAS REPEATED DUE TO A REQUEST FROM THE CLINICIAN. THE REPEAT RESULT WAS 127 MG/DL. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.
Additional Manufacturer Narrative
THE C503 ANALYZER NUMBER WAS 2058-03.