BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4210336 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-44706
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION AND HAD OPERATING CURRENTS WITHIN SPECIFICATION. THE INSULIN PUMP WAS MONITORED AND NO BLANK DISPLAY WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW AND A CRACKED CASE AT THE DISPLAY WINDOW CORNERS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE DISPLAY ON THE INSULIN PUMP IS BLANK. CUSTOMER HAS CHANGED THE BATTERY AND THE DEVICE STILL DID NOT TURN ON. CUSTOMER STATED THAT THE INSULIN PUMP DOES NOT HAVE PHYSICAL DAMAGE AND WAS NOT EXPOSED TO MOISTURE. THE CONTACTS ON THE BATTERY CAP ARE NOT MISSING OR DAMAGED AND THE BATTERY COMPARTMENT IS NOT DAMAGED OR CORRODED. CUSTOMER WAS ADVISED TO INSERT A NEW BATTERY; THE DISPLAY DID NOT RETURN. CUSTOMER INSTRUCTED TO REMOVE THE BATTERY FOR 10 MINUTES, CLEAN THE BATTERY CAP AND REINSERT THE BATTERY; DISPLAY DID NOT RETURN. BLOOD GLUCOSE VALUE WAS 248 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693393 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR