BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4230933 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48309
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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

    NO BUTTON ERROR ALARM NOTED. INSULIN PUMP HAD AN INTERMITTENT BUTTON RESPONSE ON UP ARROW BUTTON DUE TO FLATTENED DOME SWITCH. NO SUSPEND ANOMALY NOTED DURING TESTING. INSULIN PUMP HAD MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, CRACKED CASE AT DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP AND A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A BUTTON ERROR ALARM ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 88 MG/DL. CUSTOMER STATED THAT NONE OF HER BUTTONS ARE WORKING. CUSTOMER PUT THE PUMP ON SUSPEND TO TAKE A SHOWER. CUSTOMER TRIED TO UNDO THE SUSPENSION ON THE PUMP AND THEN RECEIVED THE BUTTON ERROR ALARM. CUSTOMER CANNOT CLEAR THE ALARM. INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ADVISED TO REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONAL'S INSTRUCTIONS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713279 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR