BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9150079 · Received October 3, 2019

    Report

    Report Number
    2032227-2019-72994
    Event Type
    Malfunction
    Date Received
    October 3, 2019
    Date of Event
    August 2, 2019
    Report Date
    October 3, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00763000190439
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INSULIN PUMP PASSED THE DISPLACEMENT TEST, ACTIVE CURRENT TEST AND SELF TEST. PUMP FAILED THE SLEEP CURRENT TEST DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. THE POWER MANAGEMENT TOOL INDICATED ABNORMAL BEHAVIOR OF THE LITHIUM BACKUP BATTERY LOADED VOLTAGE AS SHOWN ON THE POWER MANAGEMENT GRAPH AND CONFIRMED CHARGE OR BATTERY LASTS LESS THAN EXPECTED DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THIS MORNING HE CHANGED THE BATTERY BUT WHEN HE REMOVE THE BATTERY HE DID NOT GET THE INSERT BATTERY ALARM AND EVEN IF HE WAS PUTTING NEW BATTERIES HIS PUMP STILL SHOWED RED BATTERY ALERT ICON AND NO FAILED BATTERY ALERT. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 291 MG/DL. THEY STATED THAT HE GOT A LOW BATTERY ALERT SO HE DECIDED JUST TO CHANGE HIS BATTERY EARLY, BUT AFTER INSERTING A NEW BATTERY HE CANT HAVE THE INSULIN PUMP TO RECOGNIZE THAT THE BATTERY WAS NEW. CUSTOMER WAS NOT CALLING BACK WITHIN 1 WEEK AFTER PREVIOUSLY COMPLETING TROUBLESHOOTING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945609 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K HG3BJ4K 00763000190439

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR