BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICK-SET PARADIGM INFUSION SET

    MDR report key: 6405078 · Received March 15, 2017

    Report

    Report Number
    3003442380-2017-00006
    Event Type
    Death
    Date Received
    March 15, 2017
    Date of Event
    November 29, 2016
    Report Date
    March 17, 2017
    Manufacturer
    UNOMEDICLA A/S
    Product Code
    FPA
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED 15-MAR-2017: NO RELEVANT TESTING COULD BE PERFORMED. IF LOT INFORMATION WAS AVAILABLE, THE BATCH RECORDS AND THE COMPLAINT DATABASE WERE REVIEWED FOR RELEVANT DEVIATIONS AND SIMILAR COMPLAINTS. THIS CASE HAS BEEN CLOSED DUE TO MISSING INFORMATION. NO RELEVANT TESTING COULD BE PERFORMED. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH RECORD REVIEW OR TESTING OF RETAINED SAMPLES COULD BE PERFORMED. IF THE LOT NUMBER BECOMES AVAILABLE, THE CASE WILL BE RE-OPENED AND APPROPRIATE ACTIONS WILL BE TAKEN. UNOMEDICAL IS ACTIVELY SEEKING MORE INFORMATION ABOUT THIS INCIDENT AND WILL NO LATER THAN 18-APR-2017 SEND FOLLOW UP OR FINAL MDR REPORT.

    Additional Manufacturer Narrative · 1

    RECEIVED 15-MAR-2017: NO RELEVANT TESTING COULD BE PERFORMED. IF LOT INFORMATION WAS AVAILABLE, THE BATCH RECORDS AND THE COMPLAINT DATABASE WERE REVIEWED FOR RELEVANT DEVIATIONS AND SIMILAR COMPLAINTS. THIS CASE HAS BEEN CLOSED DUE TO MISSING INFORMATION. NO RELEVANT TESTING COULD BE PERFORMED. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH RECORD REVIEW OR TESTING OF RETAINED SAMPLES COULD BE PERFORMED. IF THE LOT NUMBER BECOMES AVAILABLE, THE CASE WILL BE RE-OPENED AND APPROPRIATE ACTIONS WILL BE TAKEN. UPDATE 17-MAR-17,CLINICAL EVALUATION: THE SPOUSE OF PATIENT CONTACTED CALL CENTER. THE SPOUSE REPORTED THE PATIENT HAD PASSED AWAY. PATIENT WAS ADMITTED TO HOSPITAL DUE TO SEPTIC AND DIABETIC ULCER IN FOOT. THE SPOUSE REPORTED THE PATIENT APPEARED TO BE GETTING SICK AND BY NEXT MORNING PATIENT WAS SO BAD THE SPOUSE HAD TO CALL AN AMBULANCE. THE AMBULANCE TOOK HIM TO HOSPITAL AND PATIENT GOT (B)(6) INFECTION, MEDICAL INTERVENTION, ANTIBIOTICS, DID NOT HELP PATIENT AS THE INFECTION WOULD NOT RESPOND TO ANTIBIOTICS, AND PATIENT PASSED AWAY A WEEK AFTER ADMISSION TO HOSPITAL. PUMP WAS REMOVED THE DAY OF ADMISSION. THERE ARE NOTHING INDICATING INFUSION SET CAUSED OR CONTRIBUTED TO THIS DEATH.

    Description of Event or Problem · 1

    (B)(4). A MALE DIABETIC PATIENTS DEATH WAS REPORTED BY HIS SIGNIFICANT OTHER. DATE OF DEATH WAS (B)(6) 2016. PATIENTS SIGNIFICANT OTHER REPORTED THAT PATIENT APPEARED ON (B)(6) 2016 TO BE GETTING SICK, HAD CHILLS BUT HAD A DOCTORS APPOINTMENT THE FOLLOWING DAY, BY NEXT MORNING HE WAS SO BAD SHE JUST CALLED AN AMBULANCE AND THE PATIENT WAS HOSPITALIZED ON (B)(6) 2016. THE PATIENT WAS WEARING PUMP UNTIL MORNING OF (B)(6) 2016 WHEN IT WAS REMOVED BY EMERGENCY WORKERS. IT WAS DISCOVERED THE PATIENT HAD OR CONTRACTED AN (B)(6) INFECTION WHICH WOULD NOT RESPOND TO ANTIBIOTICS. THE PATIENT PASSED AWAY IN HOSPITAL ON (B)(6) 2016. BLOOD GLUCOSE AT TIME OF DEATH IS UNKNOWN. OFFICIAL CAUSE OF DEATH IS LISTED AS SEPTIC AND DIABETIC ULCER IN FOOT. DOCTORS NAME: (B)(6). NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    (B)(4). A MALE DIABETIC PATIENTS DEATH WAS REPORTED BY HIS SIGNIFICANT OTHER. DATE OF DEATH WAS (B)(6) 2016. PATIENTS SIGNIFICANT OTHER REPORTED THAT PATIENT APPEARED ON (B)(6) 2016 TO BE GETTING SICK, HAD CHILLS BUT HAD A DOCTORS APPOINTMENT THE FOLLOWING DAY, BY NEXT MORNING HE WAS SO BAD SHE JUST CALLED AN AMBULANCE AND THE PATIENT WAS HOSPITALIZED ON (B)(6) 2016. THE PATIENT WAS WEARING PUMP UNTIL MORNING OF (B)(6) 2016 WHEN IT WAS REMOVED BY EMERGENCY WORKERS. IT WAS DISCOVERED THE PATIENT HAD OR CONTRACTED AN (B)(6) INFECTION WHICH WOULD NOT RESPOND TO ANTIBIOTICS. THE PATIENT PASSED AWAY IN HOSPITAL ON (B)(6) 2016. BLOOD GLUCOSE AT TIME OF DEATH IS UNKNOWN. OFFICIAL CAUSE OF DEATH IS LISTED AS SEPTIC AND DIABETIC ULCER IN FOOT. DOCTORS NAME: (B)(6). NO FURTHER INFORMATION AVAILABLE. UPDATE 17-MAR-17,CLINICAL EVALUATION: THE SPOUSE OF PATIENT CONTACTED CALL CENTER. THE SPOUSE REPORTED THE PATIENT HAD PASSED AWAY. PATIENT WAS ADMITTED TO HOSPITAL DUE TO SEPTIC AND DIABETIC ULCER IN FOOT. THE SPOUSE REPORTED THE PATIENT APPEARED TO BE GETTING SICK AND BY NEXT MORNING PATIENT WAS SO BAD THE SPOUSE HAD TO CALL AN AMBULANCE. THE AMBULANCE TOOK HIM TO HOSPITAL AND PATIENT GOT (B)(6) INFECTION, MEDICAL INTERVENTION, ANTIBIOTICS, DID NOT HELP PATIENT AS THE INFECTION WOULD NOT RESPOND TO ANTIBIOTICS, AND PATIENT PASSED AWAY A WEEK AFTER ADMISSION TO HOSPITAL. PUMP WAS REMOVED THE DAY OF ADMISSION. THERE ARE NOTHING INDICATING INFUSION SET CAUSED OR CONTRIBUTED TO THIS DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188498 QUICK-SET PARADIGM INFUSION SET QUICK-SET PARADIGM INFUSION SET FPA UNOMEDICLA A/S MMT-397 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H