BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICK-SET PARADIGM INSULIN INFUSION SET

    MDR report key: 6759470 · Received August 2, 2017

    Report

    Report Number
    3003442380-2017-00010
    Event Type
    Death
    Date Received
    August 2, 2017
    Date of Event
    July 12, 2017
    Report Date
    August 30, 2017
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244006232
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT CONCERNING A HOSPITALIZED PATIENT WHO DIED WITHIN 48 HOURS. HOSPITAL TREATMENT IS UNKNOWN. OFFICIAL CAUSE OF DEATH IS UNKNOWN. WE BELIEVE THIS OCCURRED IN (B)(6), AND THAT THE REPORTING MOTHER IS (B)(6) AND THE NOW DECEASED SON WAS IN HIS MID-FIFTIES. WE ARE TRYING TO OBTAIN FURTHER INFORMATION FROM THE DISTRIBUTOR (MEDTRONIC). WE HOPE TO SUBMIT A FOLLOW-UP MDR WITHIN A MONTH'S TIME. UPDATE PER 30-AUG-2017: OUR DISTRIBUTOR (B)(4) HAS NOR BEEN ABLE TO OBTAIN ANY FURTHER INFORMATION. WE THEREFORE CLOSE THE CASE - SHOULD NEW RELEVANT INFORMATION EMERGE, WE WILL SUBMIT AN UPDATED FOLLOW-UP REPORT TO FDA.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT CONCERNING A HOSPITALIZED PATIENT WHO DIED WITHIN 48 HOURS. HOSPITAL TREATMENT IS UNKNOWN. OFFICIAL CAUSE OF DEATH IS UNKNOWN. WE BELIEVE THIS OCCURRED IN (B)(6), AND THAT THE REPORTING MOTHER IS (B)(6) YEARS OLD AND THE NOW DECEASED SON WAS IN HIS MID-FIFTIES. WE ARE TRYING TO OBTAIN FURTHER INFORMATION FROM THE DISTRIBUTOR ((B)(4)). WE HOPE TO SUBMIT A FOLLOW-UP MDR WITHIN A MONTH'S TIME. NO SET HAS BEEN RETURNED.

    Description of Event or Problem · 1

    (B)(4). INITIAL REPORT TEXT: A MOTHER CALLS MEDTRONIC HELPDESK TO ASK THAT FUTURE SUPPLIES TO HER SON ARE CANCELLED. SUSPECTEDLY DUE TO A BENT CANNULA THE SON GOT BLOOD GLUCOSE LEVELS AT OVER 600 MG/DL AND WAS SUBMITTED TO HOSPITAL WITH A DIAGNOSIS OF DIABETIC KETOACIDOSIS. INSULIN PUMP WAS REMOVED AT HOSPITAL. SOME 48 HOURS AFTER SUBMISSION (ON (B)(6) 2017) THE PATIENT PASSED AWAY. ACCORDING TO MOTHER, THE CAUSE OF DEATH WAS 'DIABETES' AND NOT ANY OTHER HEALTH CONDITIONS. UNOMEDICAL IS ACTIVELY SEEKING FURTHER INFORMATION, SUCH AS E.G. HOSPITAL TREATMENT, OFFICIAL CAUSE OF DEATH, ON THIS COMPLAINT CASE. UPDATE PER 30-AUG-2017: IT HAS NOT BEEN POSSIBLE FOR DISTRIBUTOR ((B)(4) TO OBTAIN ANY FURTHER INFORMATION. WE BELIEVE THAT THE REPORTING MOTHER IS AN ELDERLY LADY AND THAT HER SON (THE DECEASED PATIENT) WAS IN THE MID-FIFTIES WHEN HE DIED.

    Description of Event or Problem · 1

    UNOMEDICAL REFERENCE NUMBER IS: (B)(4). A MOTHER CALLS MEDTRONIC HELP DESK TO ASK THAT FUTURE SUPPLIES TO HER SON ARE CANCELLED. SUSPECTEDLY DUE TO A BENT CANNULA THE SON GOT BLOOD GLUCOSE LEVELS AT OVER 600 MG/DL AND WAS SUBMITTED TO HOSPITAL WITH A DIAGNOSIS OF DIABETIC KETOACIDOSIS. INSULIN PUMP WAS REMOVED AT HOSPITAL. SOME 48 HOURS AFTER SUBMISSION (ON (B)(6) 2017) THE PATIENT PASSED AWAY. ACCORDING TO MOTHER, THE CAUSE OF DEATH WAS 'DIABETES' AND NOT ANY OTHER HEALTH CONDITIONS. UNOMEDICAL IS ACTIVELY SEEKING FURTHER INFORMATION, SUCH AS E.G. HOSPITAL TREATMENT, OFFICIAL CAUSE OF DEATH, ON THIS COMPLAINT CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541156 QUICK-SET PARADIGM INSULIN INFUSION SET QUICK-SET PARADIGM INSULIN INFUSION SET FPA UNOMEDICAL A/S MMT-394 05705244006232

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H