BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    630G INSULIN PUMP MMT-1715K 630G BLACK MG

    MDR report key: 8783550 · Received July 12, 2019

    Report

    Report Number
    2032227-2019-28686
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    July 1, 2019
    Report Date
    September 5, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169656840
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 PASSED THE SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT AND DISPLACEMENT TEST. NO LOW BATTERY ALARMS OR UNEXPECTED BATTERY POWER LOSS NOTED DURING TESTING. DEVICE FUNCTIONING PROPERLY. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP DID NOT RECEIVED LOW BATTERY ALERT PRIOR TO REPLACE BATTERY NOW ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 170 MG/DL. THIS WAS THE SECOND OCCURRENCE OF REPLACE BATTERY NOW ALARM. THE CUSTOMER ALSO MENTIONED POWER LOSS ALARM AND WAS ABLE TO CLEAR THE ALARM. TROUBLESHOOTING WAS PERFORMED FOR REPLACE BATTERY NOW ALARM. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580342 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K HG1JTC0 00643169656840

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR