BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL D MODULE

    MDR report key: 2801760 · Received October 23, 2012

    Report

    Report Number
    1823260-2012-05336
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 26, 2012
    Report Date
    December 6, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFR
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED DUE TO THE LACK OF INFORMATION PROVIDED. THERE WAS NO QUALITY CONTROL DATA PROVIDED TO DETERMINE THE INSTRUMENT CONDITION WHEN THE INCORRECT RESULT OCCURRED. ACCORDING TO THE FIELD SERVICE REPRESENTATIVE, THE INSTRUMENT WAS OPERATING WITHOUT ANY PROBLEMS.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE GLUCO-QUANT GLUCOSE/HK (GLUC) RESULTS ON THEIR D-MODULE. THE CUSTOMER STATED THEY HAD THREE PATIENT SAMPLES THAT HAD TO BE CORRECTED, BUT WAS NOT ABLE TO PROVIDE FURTHER DETAILS. ALL TESTING WAS PERFORMED ON THE SAME D-MODULE. THE FIRST PATIENT'S INITIAL GLUC RESULT WAS 447 MG/DL. THE INITIAL RESULT WAS QUESTIONED BY THE DOCTOR. THE REPEAT RESULT WAS 90 MG/DL. THE SECOND PATIENT'S INITIAL GLUC RESULT WAS 637 MG/DL ACCOMPANIED BY A DATA FLAG. THE CUSTOMER STATED THE SAMPLE WAS AUTOMATICALLY REPEATED AND THE RESULT WAS 134 MG/DL. THE REPEAT RESULT WAS REPORTED OUTSIDE THE LABORATORY; HOWEVER, IT IS UNCLEAR IF THE INITIAL RESULT WAS REPORTED OUTSIDE THE LABORATORY. CLARIFICATION HAS BEEN REQUESTED. ON (B)(6) 2012, THE THIRD PATIENT'S INITIAL GLUC RESULT WAS 637 MG/DL ACCOMPANIED BY A DATA FLAG. THE REPEAT RESULT WAS 134 MG/DL ACCOMPANIED BY A DATA FLAG. IT IS UNKNOWN IF THE PATIENTS WERE ADVERSELY AFFECTED BY THE EVENT. THE GLUC R1 REAGENT LOT NUMBER WAS 66343501 AND THE EXPIRATION DATE WAS 12/31/2013. THE GLUC R2 REAGENT LOT NUMBER WAS 66699501 AND THE EXPIRATION DATE WAS 01/31/2014. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE THE CAUSE OF THIS EVENT. HE PERFORMED AN AIR PURGE, REAGENT PRIME, MECHANICAL CHECK, AND THEN RAN A PRECISION TEST ON GLUC USING POOLED SAMPLE. THE MECHANICAL CHECK HAD NO ERRORS. THE R1 AND R2 DISPENSE ON THE GLUC LOOKED GOOD AND WERE GETTING RINSED PROPERLY IN THE WASH STATION. THE GLUC PRECISION TEST LOOKED GOOD. THE PHOTOMETER WAS READING IN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL D MODULE CLINICAL CHEMISTRY ANALYZER CFR ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1