BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1715KM 630G 3ML BLACK MEDI  

    MDR report key: 6669541 · Received June 27, 2017

    Report

    Report Number
    2032227-2017-23775
    Event Type
    Injury
    Date Received
    June 27, 2017
    Date of Event
    June 1, 2017
    Report Date
    June 27, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169873834
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL OVER 45 MG/DL. CUSTOMER BLOOD GLUCOSE READING ON (B)(6) 2017 WAS 160-187 MG/DL, THE INSULIN WAS NOT COMING OUT. AFTER THE BLEEDING STOPPED ON THE SET, BLOOD GLUCOSE READING WAS 54 MG/DL. CUSTOMER TOOK A TABLET THAN HIS BLOOD GLUCOSE READING WAS 45 MG/DL. ADDITIONALLY, HE TOOK FOUR MORE TABLETS, HIS BLOOD GLUCOSE READING WAS 168 MG/DL. CUSTOMER DECLINED TROUBLESHOOTING FOR LOW BLOOD GLUCOSE READING. INSULIN PUMP WILL NOT BE RETURNING FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450162 PUMP MMT-1715KM 630G 3ML BLACK MEDI   ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KM HG1SWYH 00643169873834

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other