BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHOLINESTERASE GEN.2

    MDR report key: 19839595 · Received July 26, 2024

    Report

    Report Number
    1823260-2024-02174
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    July 1, 2024
    Report Date
    September 3, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DIH
    PMA / PMN Number
    K061093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT SAMPLE APPEARED DARK AND SHOWED NO CLEAR SEPARATION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT WAS FOUND TO BE CONSISTENT WITH PRE-ANALYTICAL SAMPLE HANDLING ISSUES.

    Additional Manufacturer Narrative · 0

    THE ANALYZER SERIAL NUMBER IS (B)(6). THE QC RECOVERY DATA PROVIDED WAS ACCEPTABLE. THE FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THE ANALYZER WAS WITHIN OPERATIONAL SPECIFICATIONS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE CHE2 CHOLINESTERASE GEN. 2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 C702 MODULE. THE INITIAL CHE2 RESULT WAS 372 U/L. THE PATIENT'S CLINIC QUESTIONED THE RESULTS AS IT DID NOT MATCH THEIR CLINICAL PICTURE AND THE CUSTOMER REPEATED THE SAMPLE. THE REPEAT RESULT WAS 4450 U/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1777098 CHOLINESTERASE GEN.2 CHOLINESTERASE TEST SYSTEM DIH ROCHE DIAGNOSTICS CHE2 770125

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown