BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-01268

    MDR report key: 6649662 · Received June 19, 2017

    Report

    Report Number
    1823260-2017-01268
    Event Type
    Malfunction
    Date Received
    June 19, 2017
    Date of Event
    May 9, 2017
    Report Date
    July 27, 2017
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION BY THE MANUFACTURER FOUND THE ISSUE WAS DUE TO SOFTWARE ISSUES ON THE ANALYZER. TWO SYSTEM ERRORS OCCURRED WHICH STOPPED THE SYSTEM. ONE INVOLVED AN INCORRECT SETTING FOR THE SYSTEM NOT TO USE A SPECIFIC REACTION CELL. THIS ERROR HAS NOT RECURRED SINCE THIS SETTING WAS CHANGED. THE OTHER WAS AN ERROR INDICATING AN ISSUE WITH THE PHOTOMETER. THIS ALARM WAS THE ONLY ONE TO APPEAR TO THE CUSTOMER FOLLOWED BY AN INTERNAL PROCESS ERROR WHICH USUALLY INDICATES THE STOP OF REAGENT NEEDLES OR THE SAMPLE OR WASH UNITS. UPON INVESTIGATION IT WAS DETERMINED THIS ERROR WAS CAUSED BY ANOTHER ERROR MESSAGE INDICATING THE SYSTEM REAGENT UNLOADING TRAY WAS NOT FULLY PUSHED INTO PLACE. THIS ISSUE WAS RESOLVED BY ENSURING THE TRAY WAS PUSHED BACK CORRECTLY. NO REAGENT OR ANALYZER HARDWARE ISSUE WAS FOUND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AFTER SOFTWARE ISSUES ON THE ANALYZER, THE CUSTOMER RECEIVED A QUESTIONABLE HIGH CREJ2 CREATININE JAFFÉ GEN.2 RESULT FOR ONE PATIENT. ON (B)(6) 2017, THE RESULT FOR THE PATIENT WAS 0.547 MG/DL. ON (B)(6) 2017, THE RESULT WAS 4.998 MG/DL. THE HIGHER RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT WENT TO ANOTHER PHYSICIAN (NEPHROLOGIST) WHO TOLD THE PATIENT THAT SHE HAD A KIDNEY PROBLEM. THE PATIENT HAD TESTING PERFORMED IN ANOTHER LABORATORY, BUT NO DATA WAS PROVIDED. THE SITUATION CAUSED A LOT OF STRESS FOR THE PATIENT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 223443. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. THE QC AND CALIBRATION DATA CONFIRMED THE PROPER FUNCTION OF THE ASSAY.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR