BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANCET DEVICE MMT-395 QCKSRTR M4 13L

    MDR report key: 2479042 · Received February 24, 2012

    Report

    Report Number
    2032227-2012-04810
    Event Type
    Injury
    Date Received
    February 24, 2012
    Date of Event
    February 12, 2012
    Report Date
    February 22, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    KZH
    PMA / PMN Number
    K992300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS. PRIOR TO THE EVENT, THE CUSTOMER WENT TO BED WITH NORMAL BLOOD GLUCOSE LEVELS. DURING THE NIGHT, THE CUSTOMER WOKE UP VERY THIRSTY, AND WITH A BLOOD GLUCOSE READING OF 518 MG/DL. A BOLUS WAS GIVEN, AND THE CUSTOMER WENT TO BED. THE CUSTOMER THEN WOKE UP WITH A BLOOD GLUCOSE READING OF 534 MG/DL. THE INFUSION SET WAS REPLACED, AND FOUND THAT THE CANNULA WAS BENT. THE CUSTOMER CONTINUED EXPERIENCING HIGH BLOOD GLUCOSE LEVELS. THE INFUSION SET WAS REPLACED AGAIN, AND THE CANNULA WAS BENT AGAIN. IT WAS STATED THAT THE NEEDLE NEVER PENETRATED THE SKIN WHEN INSERTING WITH THE QUICK SERTER. THE CUSTOMER'S BLOOD GLUCOSE LEVELS BEGAN RESPONDING AFTER A COMPLETELY DIFFERENT TYPE OF INFUSION SET WAS INSERTED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANCET DEVICE MMT-395 QCKSRTR M4 13L ACCESSORIES KZH MEDTRONIC MINIMED MMT-395

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization UNOMEDICAL INFUSION SET