BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC QUICK-SET PARADIGM

    MDR report key: 7424561 · Received April 12, 2018

    Report

    Report Number
    3003442380-2018-00017
    Event Type
    Death
    Date Received
    April 12, 2018
    Date of Event
    December 7, 2017
    Report Date
    May 15, 2018
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244006577
    PMA / PMN Number
    K106648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNOMEDICAL IS ACTIVELY SEEKING FURTHER INFORMATION. PRESENTLY WE DO NOT KNOW CAUSE OF DEATH, DATE OF DEATH OR WHETHER THE INFUSION SETS MAY POSSIBLY BE CAUSALLY INVOLVED OR NOT. WE DO HOPE TO PROVIDE A FOLLOW-UP MDR WITHIN THE A MONTHS' TIME.

    Additional Manufacturer Narrative · 1

    UNOMEDICAL IS ACTIVELY SEEKING FURTHER INFORMATION. PRESENTLY WE DO NOT KNOW CAUSE OF DEATH, DATE OF DEATH OR WHETHER THE INFUSION SETS MAY POSSIBLY BE CAUSALLY INVOLVED OR NOT. WE DO HOPE TO PROVIDE A FOLLOW-UP MDR WITHIN THE A MONTHS' TIME. NEW - 15-MAY-2018: NEW INFO IS DATE OF DEATH IS (B)(6) AND THAT THE PATIENT WAS AN ADULT. RETURN OF THE USED DEVICE HAS BEEN REQUESTED BUT HAS NOT ARRIVED AT OUR TESTING FACILITY. IF WE RECEIVE THE SET WE WILL INVESTIGATE IT AND SUPPLY FDA WITH A FURTHER FOLLOW-UP EMDR. HELPDESK STAFF INFORMS THAT THE NOTES SUGGESTED THAT THE CORONER DID NOT DO AN AUTOPSY AND THERE WAS NO ACTUAL PROOF OF HYPOGLYCEMIA, BUT HE BELIEVED THAT HYPOGLYCEMIA MIGHT HAVE BEEN INVOLVED. THUS, IT REMAINS UNKNOWN IF THE PATIENT EXPERIENCED ANY MALFUNCTION WITH THE INFUSION SET. LIKEWISE, IT IS UNCERTAIN WHETHER AN EPISODE OF HYPOGLYCEMIA ACTUALLY OCCURRED PRIOR TO DEATH.

    Description of Event or Problem · 1

    (B)(4). A MOTHER OF A DIABETIC SON REPORTS THAT HER SON HAS PASSED AWAY. MOTHER HAS THE SON'S REMAINING EQUIPMENT AND HAS HEARD THAT SOME ITEMS WERE RECALLED. SHE THINK THAT HER SON'S DEATH WAS DUE TO THE PUMP WHICH HAD RECENTLY BEEN REPLACED. MOTHER INFORMS OF SIX LOTS WITH 57 OF REMAINING (UNUSED) INFUSION SETS: LOT 1-5143650(10), LOT 2-5143647(7) , LOT 3-5164672(10), LOT 4-5170768(10) , LOT 5-5143653(10) , LOT 6-5174463(10). ALL SIX ABOVE LOTS ARE MMT-386 MODELS OF QUICK-SET PARADIGM AND ARE ALL AFFECTED BY THE MEDTRONIC GLOBAL RECALL FA784 ISSUED 11-SEP-2017. AT PRESENT WE HAVE NO FURTHER INFORMATION. WE ARE TRYING TO GET MORE INFORMATION.

    Description of Event or Problem · 1

    UNOMEDICAL REFERENCE: (B)(4). A MOTHER OF A DIABETIC SON REPORTS THAT HER ADULT SON HAS PASSED AWAY AT HOME ON (B)(6) 2017. MOTHER HAS THE SON'S REMAINING EQUIPMENT AND HAS HEARD THAT SOME ITEMS WERE RECALLED. SHE THINK THAT HER SON'S DEATH WAS DUE TO THE PUMP WHICH HAD RECENTLY BEEN REPLACED. MOTHER INFORMS OF SIX LOTS WITH 57 OF REMAINING (UNUSED) INFUSION SETS: LOT 1-5143650(10), LOT 2-5143647(7), LOT 3-5164672(10), LOT 4-5170768(10), LOT 5-5143653(10), LOT 6-5174463(10). ALL SIX ABOVE LOTS ARE MMT-386 MODELS OF QUICK-SET PARADIGM AND ARE ALL AFFECTED BY THE MEDTRONIC GLOBAL RECALL FA784 ISSUED (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270465 MEDTRONIC QUICK-SET PARADIGM INSULIN PUMP INFUSION SET FPA UNOMEDICAL A/S MMT-386 05705244006577

    Patients

    Seq Age Sex Outcome Treatment
    1 Death