BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4003391 · Received August 12, 2014

    Report

    Report Number
    3004209178-2014-92641
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH BLANK DISPLAY DUE TO BROKEN SOLDER JOINT OF POWER CONNECTOR ON THE INTERFACE BOARD. NO COSMETIC DAMAGE NOTED.

    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

    CUSTOMER REPORTED A BLANK DISPLAY AFTER CHANGING THE INFUSION SET. SHE STATED THAT THE INSULIN PUMP SHOWED NO SIGNS OF DAMAGE AND THAT IT HAD NOT BEEN DROPPED OR BUMPED. SHE STATED THAT THE BATTERY CAP CONTACTS WERE NOT MISSING OR DAMAGED AND GHAT THE BATTERY COMPARTMENT AND SPRING WERE NOT DAMAGED OR CORRODED. SHE STATED THAT SHE HAD CHANGED THE BATTERY AND HELD DOWN THE ACT BUTTON UNTIL THE INSULIN PUMP VIBRATED BUT THAT THE DISPLAY DID NOT RETURN. THE BLOOD GLUCOSE READING WAS 250 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480665 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR