BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 6148144 · Received December 6, 2016

    Report

    Report Number
    2032227-2016-47822
    Event Type
    Malfunction
    Date Received
    December 6, 2016
    Date of Event
    November 8, 2016
    Report Date
    November 8, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH A CRACKED BLEEDING DISPLAY, PEELING KEYPAD OVERLAY, CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE DISPLAY WINDOW, ADDRESS LABEL PEELING AND DAMAGED AND CRACKED BATTERYTUBE THREADS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED VIA TELEPHONE CALL THAT THE INSULIN PUMP WAS CRUSHED IN A RECLINER AT THE MOVIE THEATER AND THAT THE SCREEN WAS CRUSHES. THE BLOOD GLUCOSE READING WAS NOT KNOWN. THE CALLER WAS ADVISED THAT THE CUSTOMER SHOULD DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO A BACKUP PLAN PER A HEALTH CARE PROFESSIONAL'S INSTRUCTIONS. SHE WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797542 530G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR