BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-01925

    MDR report key: 6848002 · Received September 7, 2017

    Report

    Report Number
    1823260-2017-01925
    Event Type
    Malfunction
    Date Received
    September 7, 2017
    Date of Event
    August 10, 2017
    Report Date
    November 1, 2017
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER PERFORMED PREVENTIVE MAINTENANCE ON THE ANALYZER. PRECISION STUDIES WERE PERFORMED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Additional Manufacturer Narrative · 1

    WHILE PERFORMING PREVENTIVE MAINTENANCE OF THE ANALYZER, THE FIELD SERVICE ENGINEER RE-ADJUSTED ALL AFFECTED RINSE LEVELS AND CONFIRMED THAT THE ANALYZER WAS RUNNING BACK WITHIN SPECIFICATIONS. THE CREJ ASSAY IS VERY SENSITIVE TO ANY KIND OF REAGENT OR CELL CARRYOVER. RINSE LEVELS MAY CHANGE WITH INCREASING AGE OF THE SYSTEM AND ARE STRONGLY DEPENDENT ON WATER QUALITY.

    Description of Event or Problem · 1

    THE PHOTOMETER LAMP AND CUVETTES WERE REPLACED ON THE COBAS 6000 C (501) MODULE - C501 ON 11-AUG-2017. THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR CREJ2 CREATININE JAFFÉ GEN.2 (CREJ) ON THE C501 ANALYZER ON (B)(6) 2017. THE SAMPLE WAS TESTED THREE TIMES ON THE C501 ANALYZER, RESULTING AS 86 UMOL/L, 68 UMOL/L, AND 59 UMOL/L. THE SAMPLE WAS ALSO TESTED THREE TIMES ON A DIFFERENT C501 ANALYZER, RESULTING AS 80 UMOL/L, 86 UMOL/L, AND 86 UMOL/L. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE CREJ REAGENT LOT NUMBER WAS 222601. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED.

    Patients

    Seq Age Sex Outcome Treatment
    1