BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4221473 · Received November 3, 2014

    Report

    Report Number
    2032227-2014-46922
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 31, 2014
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ALL BUTTONS FUNCTIONING PROPERLY. NO DAMAGE IN THE KEYPAD ASSEMBLY NOTED. NO UNLOCKED J2/LIQUID CRYSTAL DISPLAY KEYPAD CONNECTOR DURING VISUAL INSPECTION. INSULIN PUMP MONITORING IN 50 C OVEN FOR SEVERAL DAYS AND NO UNEXPECTED NOISE NOTED. NO COSMETIC DAMAGE NOTED. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP BUTTONS WERE UNRESPONSIVE. CUSTOMER STATED SHE REMOVED THE BATTERY DUE NOISE AND REINSERTED THE BATTERY AND BUTTONS WERE UNRESPONSIVE. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. 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
    701394 530G INSULIN PUMP OZO OZO MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR