BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4085887 · Received September 12, 2014

    Report

    Report Number
    2032227-2014-21959
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ALL BUTTONS FUNCTIONING PROPERLY. NO UNLOCKED J2/LCD KEYPAD CONNECTOR DURING VISUAL INSPECTION. PUMP RECEIVED WITH NORMAL OPERATING CURRENTS. NO UNEXPECTED BATTERY OUT LIMIT ALARM NOTED. NO UNEXPECTED SOLID CIRCLE DURING TESTING. NO COSMETIC DAMAGE. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4) SITE PER VARIANCE 5.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD UNRESPONSIVE KEYPAD. CUSTOMER STATED GOT BATTERY OUT LIMIT. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE WAS 208 MG/DL. ADVISED CUSTOMER THE INSULIN PUMP WOULD BE REPLACED. ADVISED TO DISCONTINUE USING THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROVIDER. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566007 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR