BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3973898 · Received August 1, 2014

    Report

    Report Number
    2032227-2014-05101
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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 THROUGH THE OUTREACH PROGRAM THAT HE HAD A LOW BLOOD GLUCOSE EVENT WHERE PARAMEDICS WERE CALLED TO HIS HOUSE. CALLER DISCONNECTED BEFORE PROVIDING FURTHER INFORMATION. CUSTOMER WAS CALLED BACK LATER, BUT THERE WAS NO ANSWER AND NO MAILBOX SET UP TO RECEIVED VOICEMAILS. A SECOND ATTEMPT WAS MADE TO CONTACT CUSTOMER. WHEN HE ANSWERED THE PHONE, HE SAID IT WAS NOT A GOOD TIME FOR HIM TO SPEAK. CUSTOMER WAS ADVISED THAT HE NEEDED TO PROVIDE MORE INFORMATION ABOUT THE LOW BLOOD GLUCOSE EVENT. HE SAID HE UNDERSTOOD AND SCHEDULED A TIME TO FOLLOW UP THE NEXT DAY. WHEN CUSTOMER WAS CALLED, THERE WAS NO ANSWER AND NO WAY TO LEAVE A VOICEMAIL. THE LAST TIME CUSTOMER WAS CALLED, A NON-HIPAA WOMAN PICKED ANSWERED AND STATED A BUSINESS NAME. A GENERAL MESSAGE WAS LEFT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450989 530G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization