BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP MMT-551NAL

    MDR report key: 8726030 · Received June 24, 2019

    Report

    Report Number
    2032227-2019-20248
    Event Type
    Malfunction
    Date Received
    June 24, 2019
    Date of Event
    June 16, 2019
    Report Date
    July 31, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169503649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    DEVICE ALARMED MOTOR ERROR DURING BASIC OCCLUSION TEST DUE TO FAULTY FORCE SENSOR RESISTOR (GOLD). UNABLE TO PERFORM BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST OR VERIFY A33 ALARM DUE TO MOTOR ERROR ALARM. HOWEVER, DEVICE PASSED REWIND TEST AND DISPLACEMENT TEST. MOTOR PASSED MOTOR TEST.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLESHOOTING WAS NOT PERFORMED. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519905 530G INSULIN PUMP MMT-551NAL ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL A4551NALJ 00643169503649

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR