BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN REAL-TIME MONITIOR

    MDR report key: 2940013 · Received February 1, 2013

    Report

    Report Number
    2032227-2013-00440
    Event Type
    Injury
    Date Received
    February 1, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    UNABLE TO VIBRATE DUE TO BROKEN VIBRATOR WIRE. THE ALARM MODE FUNCTIONED PROPERLY. NO HIGH/LOW ALARM TEST ANOMALIES.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE PARAMEDICS WERE CALLED TO ASSIST CUSTOMER DUE LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 30 MG/DL AT THE TIME THE PARAMEDICS ARRIVED. CUSTOMER STATED THAT HE TREATED FOR HIGH BLOOD GLUCOSE WITH MANUAL INJECTION, AND HIS BLOOD GLUCOSE WAS DROPPING VERY FAST AFTER TREATING, AND BECOME INCOHERENT. PARAMEDICS WERE CALLED AND TREATED CUSTOMER AT HOME WITH GLUCOSE SHOT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44262 GUARDIAN REAL-TIME MONITIOR CGM MDS MEDTRONIC MINIMED CSS7100NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization