BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12364203 · Received August 25, 2021

    Report

    Report Number
    2032227-2021-184349
    Event Type
    Malfunction
    Date Received
    August 25, 2021
    Date of Event
    June 16, 2021
    Report Date
    August 25, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000643169656840
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETAINER RING = CLEAR. THUS SOFTWARE WAS UTILIZED AND DOWNLOADED TRACE/HISTORY FILES PROPERLY. UNIT PASSED DISPLACEMENT AND SELF TEST. TOGGLED ON/OFF AND INCREASED/DECREASED VOLUME WITH THE AUDIO FEATURE FUNCTIONING PROPERLY. NO AUDIO/VIBRATE/ABSENCE OF ALARM ANOMALIES NOTED DURING TESTING. HARDWARE LOW FAILURES ALARM (VARIABLE 3) CONFIRMED IN THE PUMP HISTORY. USED A TEST KEYPAD ASSEMBLY AND PERFORMED THE SELF-TEST AND NO HARDWARE LOW FAILURES ALARM AND THE AUDIO TONE VOLUME FUNCTIONING PROPERLY. PERFORM VISUAL INSPECTION ON THE KEYPAD TRACES AND FOUND CRACKED SOLDER JOINT AT PIN 6 (SDA) ON KEYPAD ASSEMBLY. IN CONCLUSION, HARDWARE LOW FAILURES ALARM (VARIABLE 3) CONFIRMED IN THE PUMP HISTORY DUE TO CRACKED SOLDER JOINT AT PIN 6 (SDA) ON KEYPAD ASSEMBLY. NO MOISTURE DAMAGE ON THE ELECTRONICS, BATTERY TUBE, MOTOR, VIBRATOR, AND KEYPAD ASSEMBLY DURING VISUAL INSPECTION. UNIT RECEIVED WITH CRACKED KEYPAD OVERLAY. UNIT P-CAP / TEST RESERVOIR LOCK IN PLACE PROPERLY.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP SHOWED MULTIPLE PUMP ERRORS AFTER INSULIN PUMP RESET. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND COMPLETE INSULIN PUMP REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. INSULIN PUMP WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265937 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K HG27ZQG 000000643169656840

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR