BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3974406 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-89115
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP POWER UP PROPERLY AFTER THE BATTERY INSTALLATION. THE DEVICE WAS RECEIVED WITH OPERATING CURRENTS WITHIN SPECIFICATION. THE INSULIN PUMP WAS MONITORED AND NO BLANK DISPLAY ANOMALIES OR UNEXPECTED BATTERY OUT LIMIT ALARMS WERE NOTED. NO DAMAGE ON THE LCD ISOLATION TAPE NOTED. THE UNIT WAS RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNERS AND BATTERY TUBE THREADS, AND MINOR SCRATCHED DISPLAY WINDOW.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP RECEIVED A BATTERY OUT LIMIT ALARM AND HAD A SCRATCHED LCD SCREEN. THE CUSTOMER'S BLOOD GLUCOSE WAS 193 MG/DL AND DECREASED TO 187 MG/DL AT THE TIME THE ISSUE WAS REPORTED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450457 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP A2751NAPJ

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR