BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXLAB

    MDR report key: 6645998 · Received June 16, 2017

    Report

    Report Number
    3010825766-2017-00003
    Event Type
    Malfunction
    Date Received
    June 16, 2017
    Date of Event
    May 17, 2017
    Report Date
    June 16, 2017
    Manufacturer
    INPECO SA
    Product Code
    JQP
    PMA / PMN Number
    K121012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS INVESTIGATED BY INPECO, WHICH DETERMINED THAT THE ABNORMAL NUMBER OF CLOT DETECTION ERRORS AND THE SAMPLES DILUTION WERE DUE TO AN INCORRECT MAINTENANCE OF THE ALIQUOTER UNIT. SPECIFICALLY, THE USER DID NOT USE DISTILLED OR DE-IONIZED WATER AS CLEARLY INDICATED IN THE SERVICE MANUAL. AS A CONSEQUENCE, ALIQUOTER UNIT COMPONENTS WERE DAMAGED. AS CORRECTIVE ACTION THE DISTRIBUTOR HAS REPLACED THE DAMAGED ALIQUOTER UNIT COMPONENTS. THE RELEVANT PART OF THE SERVICE MANUAL HAS BEEN REVIEWED AND IT HAS BEEN CONFIRMED THE INSTRUCTIONS ARE CLEAR AND NOT MISLEADING. THE PRODUCT DESIGN AND LABELING ARE CONSIDERED ADEQUATE. NO PRODUCT CHANGE FORESEEN. THIS DEVICE IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    INPECO WAS NOTIFIED BY THE FLEXLAB DISTRIBUTOR ABOUT AN ISSUE WITH THE ALIQUOTER UNIT. SPECIFICALLY, A SMALL VOLUME OF WATER FROM THE ALIQUOTER PIPETTOR CIRCUIT WAS DISPENSED INTO SAMPLE TUBES DILUTING THEM. THE DISTRIBUTOR REFERRED ALSO THAT THE CUSTOMER EXPERIENCED AN UNEXPECTED INCREASED NUMBER OF ERRORS (I.E. CLOT DETECTION ERROR) THE DAYS BEFORE THE EVENT. AS IMMEDIATE ACTION THE DISTRIBUTOR SET THE ALIQUOTER MODULE OFF-LINE. INPECO REVIEWED THE LOG FILES AND IDENTIFIED THE SAMPLE TUBES PROCESSED BY ALIQUOTER POTENTIALLY AFFECTED BY DILUTION. THE LIST OF SAMPLES ID WAS COMMUNICATED TO THE CUSTOMER IN ORDER TO LET THEM DOUBLE CHECK THE TESTS RESULT. THERE WAS NO DEATH NEITHER SERIOUS INJURY TO ANY PATIENT DUE TO ERRONEOUS TEST RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426792 FLEXLAB LABORATORY AUTOMATION SYSTEM JQP INPECO SA

    Patients

    Seq Age Sex Outcome Treatment
    1