BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-01504

    MDR report key: 6727449 · Received July 20, 2017

    Report

    Report Number
    1823260-2017-01504
    Event Type
    Malfunction
    Date Received
    July 20, 2017
    Date of Event
    June 29, 2017
    Report Date
    July 20, 2017
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER EXPERIENCED AN ISSUE WITH LOW PRESSURE IN THE VACUUM TANK MANY TIMES SINCE (B)(64 2017. THE FIELD SERVICE REPRESENTATIVE FOUND THERE WAS A VACUUM FAILURE OF THE SAMPLE RINSE MECHANISM AND THE VACUUM PUMP DIAPHRAGM WAS PERFORATED. HE REPLACED THE DIAPHRAGM AND RAN QC WITH ALL RESULTS WITHIN SPECIFICATION. AFTER THE SERVICE VISIT, THE CUSTOMER REPEATED PATIENT SAMPLES THAT HAD LOW RESULTS FOR CA2 CALCIUM GEN.2 ON ANOTHER COBAS 8000 C (702) MODULE. OF THE DATA PROVIDED FOR FOUR PATIENT SAMPLES, ONLY THE RESULTS FOR THREE OF THE SAMPLES WERE DISCREPANT. PATIENT 1 INITIAL RESULT WAS 6.71 MG/DL AND THE REPEAT RESULT WAS 8.9 MG/DL. PATIENT 2 INITIAL RESULT WAS 6.38 MG/DL AND THE REPEAT RESULT WAS 8.6 MG/DL. PATIENT 3 INITIAL RESULT WAS 7.68 MG/DL AND THE REPEAT RESULT WAS 9.8 MG/DL. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT AND CORRECTED REPORTS WERE ISSUED. PATIENT 1 WAS ALREADY IN THE HOSPITAL AND WAS TREATED WITH CALCIUM BASED ON THE INITIAL LOW RESULT. THE CUSTOMER WAS UNABLE TO PROVIDE ANY FURTHER DETAILS. NO ADVERSE EVENT WAS REPORTED. THE REAGENT LOT NUMBER WAS 221425. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. NO OTHER ASSAYS WERE AFFECTED.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR