BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4200270 · Received September 17, 2014

    Report

    Report Number
    2032227-2014-23959
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    June 18, 2014
    Report Date
    August 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH BLEEDING AND CRACKED LCD GLASS. INSULIN PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP HAD SOME BLACK MARKS ON THE DISPLAY WHICH MADE IT DIFFICULT TO READ. CUSTOMER REPORTED THAT HE WAS UNABLE TO READ THE BATTERY LIFE INDICATOR AND THAT HE HAD AN ALERT THAT WAS ALSO UNCLEAR AT THE TIME OF THE CALL. CUSTOMER STATED THAT THE INSULIN PUMP HAD RECENTLY BEEN CLOSED IN A CAR DOOR. BLOOD GLUCOSE LEVEL AT THE TIME OF THE CALL WAS NOT PROVIDED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577186 530G INSULIN PUMP OZO MEDTRONIC MINIMED MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR