BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4181471 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39581
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 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

    THE INSULIN PUMP RECEIVED WITH CURRENTS IN SPECIFICATIONS. NO UNEXPECTED LOW BATTERY ALARM. THE DEVICE HAD MINOR SCRATCHED LCD WINDOW, CRACKED CASE NEAR DISPLAY WINDOW CORNERS, AND CRACKED RESERVOIR TUBE LIP.

    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)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RECEIVING A LOW BATTERY ALARM. HE HAD REPLACED HIS BATTERY AND NOW HIS INSULIN PUMP WOULD NOT TURN ON. THE CUSTOMER STATED HE HAD TRIED 9 DIFFERENT BATTERIES. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. HE ALSO REPORTED THAT HIS BATTERY DOES NOT LAST MORE THAN A WEEK. CUSTOMER ALSO REPORTED THAT HE DID NOT RECEIVE A WEAK BATTERY ALERT. THE CUSTOMER REQUESTED A NEW INSULIN PUMP. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661218 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR