BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK-SET PARADIGM

    MDR report key: 6095418 · Received November 11, 2016

    Report

    Report Number
    3003442380-2016-00017
    Event Type
    Injury
    Date Received
    November 11, 2016
    Date of Event
    March 10, 2016
    Report Date
    April 25, 2017
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K011071
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 11-NOV-2016: THIS IS AN INITIAL MDR REPORT. WE ARE ACTIVELY SEEKING MORE INFORMATION. PRESENTLY WE CANNOT EXCLUDE THAT INFUSION SET(S) MAY HAVE BEEN A CONFOUNDING/CONTRIBUTION FACTOR. NEW INFORMATION >>MAY<< CAUSE US TO WITHDRAW THE MDR SUBMISSION IF IT CONCLUSIVELY IS DEMONSTRATED THAT ONLY INSULIN PUMP FAILURE(S) CAUSED THE COMA, HEART FAILURE AND HOSPITALISATION. ON 25-APR-2017: NO FURTHER INFORMATION CAN BE OBTAINED. CASE IS CLOSED. IF NEW RELEVANT INFORMATION BECOME AVAILABLE, CASE WILL BE RE-OPENED AND RE-SUBMITTED.

    Additional Manufacturer Narrative · 1

    ON 11-NOV-2016: THIS IS AN INITIAL MDR REPORT. WE ARE ACTIVELY SEEKING MORE INFORMATION. PRESENTLY WE CANNOT EXCLUDE THAT INFUSION SET(S) MAY HAVE BEEN A CONFOUNDING/CONTRIBUTION FACTOR. NEW INFORMATION >>MAY<< CAUSE US TO WITHDRAW THE MDR SUBMISSION IF IT CONCLUSIVELY IS DEMONSTRATED THAT ONLY INSULIN PUMP FAILURE(S) CAUSED THE COMA, HEART FAILURE AND HOSPITALISATION.

    Description of Event or Problem · 1

    (B)(4). THIS CASE WAS AT FIRST ASSESSED AS A PUMP-RELATED CASE WITH RESPECT TO COMA AND HOSPITALISATION. DUE TO ERRING AT THE SIDE OF CAUTION, WE HAVE RE-ASSESSED THE CASE TODAY AS POSSIBLY ALSO BEING INFUSION SET RELATED. UNOMEDICAL IS ACTIVELY SEEKING MORE INFORMATION ON THIS CASE. A MALE DIABETIC PATIENT IS RECEIVING INSULIN VIA AN INSULIN PUMP AND AN INSULIN INFUSION SET. HE REPORTS A NUMBER OF ISSUES SEEMINGLY PUMP-RELATED OVER RECENT TIME INCLUDING ELEVATED BLOOD GLUCOSE (BG) LEVELS OF UP TO 500 MG/DL. HE FURTHER REPORTS A HOSPITALISATION ON (B)(6) 2016 DUE TO DIABETIC KETOACIDOSIS (DKA), COMA, HEART FAILURE AND 'FLAT LINING'. PATIENT IS TRANSFERRED FROM ER AT (B)(6) MEDICAL CENTER, (B)(6) TO (B)(6) MEDICAL CENTER, (B)(6) AND RELEASED (B)(6) 2016. MOST OF THE AVAILABLE INFORMATION POINTS TO PUMP ISSUES/FAILURE(S) BEING THE ROOT CAUSE OF HIS PROBLEMS. HOWEVER, THE INFORMATION ALSO CONTAIN THE TEXT "SIGNIFICANT EVENTS LEADING TO THE HOSPITALIZATION: HE HAS BEEN RUNNING HIGH BG AND FEW BENT CANNULAS AND A NO DELIVERY ALARM". DUE TO THIS, WE CANNOT PRESENTLY COMPLETELY EXCLUDE THAT INFUSION SET(S) MAY HAVE BEEN CONFOUNDING/CONTRIBUTING FACTOR(S) LEADING UP TO THE COMA AND SUBSEQUENT HOSPITALISATION. ON 25-APR-2017: NO FURTHER INFORMATION CAN BE OBTAINED. CASE IS CLOSED. IF NEW RELEVANT INFORMATION BECOME AVAILABLE, CASE WILL BE RE-OPENED AND RE-SUBMITTED.

    Description of Event or Problem · 1

    (B)(4). THIS CASE WAS AT FIRST ASSESSED AS A PUMP-RELATED CASE WITH RESPECT TO COMA AND HOSPITALISATION. DUE TO ERRING AT THE SIDE OF CAUTION, WE HAVE RE-ASSESSED THE CASE TODAY AS POSSIBLY ALSO BEING INFUSION SET RELATED. UNOMEDICAL IS ACTIVELY SEEKING MORE INFORMATION ON THIS CASE. A MALE DIABETIC PATIENT IS RECEIVING INSULIN VIA AN INSULIN PUMP AND AN INSULIN INFUSION SET. HE REPORTS A NUMBER OF ISSUES SEEMINGLY PUMP-RELATED OVER RECENT TIME INCLUDING ELEVATED BLOOD GLUCOSE (BG) LEVELS OF UP TO 500 MG/DL. HE FURTHER REPORTS A HOSPITALISATION ON (B)(6) 2016 DUE TO DIABETIC KETOACIDOSIS (DKA), COMA, HEART FAILURE AND 'FLAT LINING'. PATIENT IS TRANSFERRED FROM ER AT (B)(6) TO (B)(6) AND RELEASED (B)(6) 2016. MOST OF THE AVAILABLE INFORMATION POINTS TO PUMP ISSUES/FAILURE(S) BEING THE ROOT CAUSE OF HIS PROBLEMS. HOWEVER, THE INFORMATION ALSO CONTAIN THE TEXT "SIGNIFICANT EVENTS LEADING TO THE HOSPITALIZATION: HE HAS BEEN RUNNING HIGH BG AND FEW BENT CANNULAS AND A NO DELIVERY ALARM." DUE TO THIS, WE CANNOT PRESENTLY COMPLETELY EXCLUDE THAT INFUSION SET(S) MAY HAVE BEEN CONFOUNDING/CONTRIBUTING FACTOR(S) LEADING UP TO THE COMA AND SUBSEQUENT HOSPITALISATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747334 QUICK-SET PARADIGM INSULIN INFUSION SET FPA UNOMEDICAL A/S MMT-397 5056237

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L