BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4130074 · Received September 18, 2014

    Report

    Report Number
    2032227-2014-24517
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD BATTERY CAP DAMAGE DUE TO A STRIPPED COIN SLOT. THE DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED. NO BATTERY OUT LIMIT ALARM COULD BE VERIFIED AND THE OPERATING CURRENTS COULD NOT BE TESTED DUE TO THE BLANK DISPLAY. THE INSULIN PUMP HAD A BLANK DISPLAY DUE TO A LOOSE BATTERY TUBE CONNECTOR. THE INSULIN PUMP WAS RECEIVED WITH CRACKED BATTERY TUBE THREADS AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD A BLANK DISPLAY AFTER IT FELL ON THE FLOOR. THERE WERE NO SIGNS OF PHYSICAL DAMAGE. THE CUSTOMER'S BLOOD GLUCOSE WAS 233 MG/DL. WHILE ON THE PHONE, THE CUSTOMER TRIED OPENING THE BATTERY CAP AND STATED THAT THE DISPLAY RETURNED AND NO THE INSULIN PUMP WAS ALARMING BATTER OUT LIMITED. THE CUSTOMER WAS UNABLE TO REMOVE THE CAP. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579590 530G INSULIN PUMP OZO MEDTRONIC MINIMED MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR