BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 5240969 · Received November 20, 2015

    Report

    Report Number
    2032227-2015-68341
    Event Type
    Malfunction
    Date Received
    November 20, 2015
    Date of Event
    November 5, 2015
    Report Date
    November 5, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED FOR A MOTOR ERROR DURING THE REWIND DUE TO A MOTOR ENCODER SIGNAL OUT OF PHASE. THE FUNCTIONAL TESTING COULD NOT BE COMPLETED DUE TO THE MOTOR ERROR ALARM. NO DAMAGE TO THE RESERVOIR COMPARTMENT WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITHOUT THE ORIGINAL RESERVOIR. THE INSULIN PUMP HAD A CRACKED CASE AT THE DISPLAY WINDOW CORNERS. THE BUTTONS RESPONDED PROPERLY.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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 VIA PHONE CALL THAT THE INSULIN PUMP HAD MULTIPLE NO DELIVERY ALARMS. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS NOT PROVIDED. THE CUSTOMER ALSO STATED THAT THE PISTON WENT TO THE TOP OF THE RESEVOIR, BUT SHE DID NOT SEE ANY DROPS OF INSULIN EXITING. THE CUSTOMER REPORTED THAT THE KEYPAD BECAME UNRESPONSIVE DURING THE REWIND PROCESS. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771562 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR