BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4103389 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-25262
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ALL BUTTONS FUNCTIONING PROPERLY. NO COSMETIC DAMAGE NOTED. HOWEVER, FOUND UNLOCKED J2/LCD KEYPAD CONNECTOR DURING VISUAL INSPECTION. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP RETURNED A MESSAGE TO USE THE BOLUS WIZARD PAIRED WITH A LIGHT EACH TIME SHE TRIED TO BOLUS. CUSTOMER ALSO REPORTED RECEIVING WEAK SIGNAL ALARMS WHEN THE PUMP WAS IN HER POCKET. BLOOD GLUCOSE LEVEL WAS 138 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585104 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR