BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-01155

    MDR report key: 6611599 · Received June 5, 2017

    Report

    Report Number
    1823260-2017-01155
    Event Type
    Malfunction
    Date Received
    June 5, 2017
    Date of Event
    May 21, 2017
    Report Date
    June 13, 2017
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION COULD EXCLUDE A GENERAL ISSUE WITH REAGENT AS CALIBRATION WAS ACCEPTABLE AND BOTH CONTROL LEVELS WERE WELL WITHIN SPECIFICATIONS. THE REACTION KINETICS WERE FOUND TO BE NORMAL. BASED ON THE FIELD SERVICE REPRESENTATIVE'S FINDINGS, THE MOST PROBABLE CAUSE OF THE ISSUE WAS A SPORADIC CONTAMINATION OR CARRYOVER EFFECT DUE TO INEFFICIENT WASHING. THE INSTRUMENT IS NOW WORKING WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE HIGH ETOH2 ETHANOL GEN.2 RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 46 MMOL/L AND WAS REPORTED TO THE ER. THE HUSBAND OF THE PATIENT QUESTIONED THE RESULT AND A NEW SAMPLE WAS DRAWN. THE RESULT FROM THE NEW SAMPLE WAS -2 MMOL/L WITH A DATA FLAG. THE ORIGINAL SAMPLE WAS REPEATED ON THE ORIGINAL ANALYZER AND ANOTHER ANALYZER. THE RESULT FROM BOTH ANALYZERS WAS 0 MMOL/L WITH A DATA FLAG. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 223279. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. THE QC RESULTS WERE WITHIN SPECIFICATION BEFORE AND AFTER THE ERRONEOUS RESULT WAS GENERATED. THE FIELD SERVICE REPRESENTATIVE FOUND THERE WAS A MISADJUSTED GEAR PUMP. HE REPLACED THE SAMPLE PROBE, BACKFLUSHED THE REAGENT AND SAMPLE PROBE, INCREASED THE GEAR PUMP PRESSURE, AND CHECKED THE RINSE MECHANISM VOLUMES AND WASHSTATION WATER RINSE PRESSURE. HE RAN PERFORMANCE TESTING WITH ALL RESULTS NEGATIVE. THE CUSTOMER RAN QC WITH RESULTS WITHIN RANGE.

    Patients

    Seq Age Sex Outcome Treatment
    1