BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSCAN PANELS

    MDR report key: 4173501 · Received October 10, 2014

    Report

    Report Number
    2919016-2014-00040
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    LRG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER INDICATED THAT THE MICROSCAN BARCODE PRINTER WAS NOT AT FAULT FOR THIS ISSUE. THE MIXED UP OF SPECIMEN ISSUES IN THEIR FACILITY HAVE BEEN RESOLVED WITH THE IMPLEMENTATION OF A NEW PROCESS TO CONFIRM LABELS BEFORE ATTACHING TO THE PANELS. THE MODEL NUMBERS OF THE AFFECTED 11 PANELS ERE NOT REPORTED. CALIBRATION OF THE BARCODE PRINTER WAS PERFORMED ON (B)(6) 2014 AND THE BARCODE PRINTER SKIPPED BLANK LABELS WAS RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BARCODE PRINTER WAS SKIPPING BLANK LABELS AND THE ONLY WAY TO GET IT TO STOP WOULD BE TO CYCLE AND POWER ON THE PRINTER. THE CUSTOMER HAD TO REPAIR THE BAR CODE LABEL AND THAT IS WHEN THE PRINT ORDER WAS AFFECTED AND RESULTED IN A MIX UP OF LABELS. CUSTOMER INDICATED THAT BARCODE PRINTER WAS NOT THE CAUSE OF MIXED UP LABELS. APPROXIMATELY 11 PANELS WERE AFFECTED WITH INCORRECT BARCODES. IT IS UNK HOW MANY INCORRECT RESULTS WERE INITIALLY REPORTED TO THE PHYSICIANS. WHEN THE CUSTOMER DISCOVERED THE MIXED UP, ISOLATES WERE RE-TESTED. THE CORRECTED RESULTS WERE ISSUED AND REPORTED TO THE PHYSICIAN. IT IS UNK WHEN THE LABEL MIX UP STARTED TO OCCUR. THE SPECIFIC INFO ABOUT THE TREATMENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642631 MICROSCAN PANELS NONE LRG SIEMENS HEALTHCARE DIAGNOSTICS INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1