BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4840848 · Received June 12, 2015

    Report

    Report Number
    3004209178-2015-63736
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    March 25, 2015
    Report Date
    May 25, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS UNABLE TO VIBRATE DUE TO A BROKEN BLACK VIBRATOR WIRE. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, SCRATCHED RESERVOIR TUBE WINDOW AND A 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT SHE HAD A VIBRATE ANOMALY ON THE INSULIN PUMP. CUSTOMER STATED THAT THE VIBRATE FEATURE WAS NOT WORKING. CUSTOMER STATED THAT SHE PRESSED THE ACT BUTTON AFTER USING THE UP ARROW BUTTON TO SET AN EASY BOLUS AMOUNT. CUSTOMER WAS ASSISTED IN PERFORMING A SELF TEST. CUSTOMER STATED THAT THE PUMP DID NOT VIBRATE DURING THE VIBRATE TEST. CUSTOMER WAS ADVISED THAT THE PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ALSO ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384921 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR