BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 6047140 · Received October 21, 2016

    Report

    Report Number
    2032227-2016-33650
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Date of Event
    December 18, 2015
    Report Date
    October 26, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED DISPLACEMENT TEST, REWIND TEST, BASIC OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST, OCCLUSION TEST, SELF-TEST AND A21 ERROR TEST. PUMP PASSED ALL OPERATING CURRENTS TESTED WITHIN THE SPECIFICATION RANGE AND PASSED OFF NO POWER TEST. THE INSULIN PUMP WAS PROGRAMMED WITH MULTIPLE BOLUS DELIVERIES, MONITORED AND TESTED WITH ALL BOLUS REGISTERED PROPERLY AND NO GAPS IN BETWEEN BOLUS HISTORY NOTED. THE INSULIN PUMP WAS RECEIVED WITH CRACKED RESERVOIR TUBE LIP, CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS, MINOR SCRATCHES ON DISPLAY WINDOW AND MISSING THE END CAP STICKER.

    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 VIA PHONE CALL THAT THEIR BOLUS DID NOT RECORD IN THE BOLUS HISTORY. THE INSULIN PUMP DISPLAYED THAT SHE DID NOT BOLUS FOR EIGHT HOURS. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697759 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR