BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-01932

    MDR report key: 6854492 · Received September 11, 2017

    Report

    Report Number
    1823260-2017-01932
    Event Type
    Malfunction
    Date Received
    September 11, 2017
    Date of Event
    August 21, 2017
    Report Date
    September 11, 2017
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED LOW RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED FOR CA2 CALCIUM GEN.2 (CA) ON A COBAS 8000 C 702 MODULE (C702). THE CUSTOMER PROVIDED DATA FOR ONE PATIENT SAMPLE THAT HAD AN ERRONEOUS INITIAL CA RESULT THAT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED AS 1.29 MMOL/L. THE SAMPLE WAS REPEATED, RESULTING AS 2.50 MMOL/L. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE CA REAGENT LOT NUMBER WAS 221425. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. THE WATER SUPPLY QUALITY AT THE CUSTOMER SITE WAS QUESTIONABLE. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. ADDITIONAL INFORMATION REQUIRED FOR THE INVESTIGATION WAS REQUESTED, BUT NOT PROVIDED. THE CUSTOMER HAS CONFIRMED THAT THEY HAVE NOT HAVING ANY FURTHER ISSUES.

    Patients

    Seq Age Sex Outcome Treatment
    1