BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION SET COMFORT, MODEL 100-006-01

    MDR report key: 5220584 · Received November 12, 2015

    Report

    Report Number
    3003442380-2015-00019
    Event Type
    Injury
    Date Received
    November 12, 2015
    Date of Event
    October 5, 2015
    Report Date
    November 27, 2015
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K972135
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLAIMED FAILURE CANNOT BE CONFIRMED. THE COMPLAINT HAS BEEN REVIEWED BASED ON THE CUSTOMER COMPLAINT DESCRIPTION AND EVALUATES THAT NO FURTHER INVESTIGATION CAN BE PERFORMED BEFORE EITHER USED SAMPLES ARE RECEIVED FOR TESTING OR THAT THE LOT NUMBER IS PROVIDED TO INVESTIGATE A POTENTIAL ORIGIN OF THE PRODUCT FAILURE IN THE DEVICES MANUFACTURING TRACEABILITY DOCUMENTS. UNOMEDICAL CLINICAL EVALUATION: NOT ENOUGH INFORMATION AVAILABLE TO PERFORM A CLINICAL EVALUATION. THE CHAIN OF EVENTS IS NOT CLEAR. PATIENT HOSPITALIZATION DUE TO DIABETIC COMA (THE TERM REFERRING TO WHEN PHYSICIANS ARE CONFRONTED WITH UNCONSCIOUS PATIENTS ABOUT WHOM NOTHING IS KNOWN EXCEPT THAT PATIENT HAVE DIABETES). THE USED INFUSION SET HAS NOT BEEN RETURNED FOR TESTING AND IT IS NOT CLEAR WHETHER THIS INCIDENT IS ASSOCIATED WITH THE PUMP OR INFUSION SET. MORE INFORMATION IS NECESSARY. IF ANY FURTHER RELEVANT INFORMATION IS OBTAINED THE CASE WILL BE RE-OPENED AND WE WILL ACT APPROPRIATELY, INCLUDING RE-SUBMISSION OF THE UPDATED CASE. NO INFUSION SET RETURNED TO UNOMEDICAL.

    Additional Manufacturer Narrative · 1

    AS INFUSION SET LOT NUMBER IS UNKNOWN AND NO INFUSION SET(S) HAVE BEEN RETURNED FOR INVESTIGATIONS, UNOMEDICAL IS UNABLE TO INVESTIGATE ANY INFUSION SETS, INCLUDING OUR LOT REFERENCE SAMPLES. PRESENTLY ANY INFUSION SET FAILURE(S) IS UNCONFIRMED. FURTHER INFORMATION, IF OBTAINED, WILL EXPECTEDLY BE PROVIDED IN A FOLLOW-UP OR FINAL MDR REPORT. NEXT REPORT TARGET DATE IS 04-DEC-2015. NO INFUSION SET RETURNED TO UNOMEDICAL.

    Description of Event or Problem · 1

    (B)(4). A DIABETIC, 40 YEAR OLD FEMALE PATIENT IS BEING TREATED WITH INSULIN VIA AN INSULIN PUMP AND A COMFORT INFUSION SET (MODEL 100-006-01). ON (B)(6) 2015 THE PATIENT IS REPORTED HOSPITALIZED FOR 'DIABETIC COMA' AFTER A 911 CALL. SHE IS TREATED BY HCPS. TREATMENT (AND OUTCOME) IS UNKNOWN. LEVELS OF BLOOD GLUCOSE AND KETONES ARE UNKNOWN. OTHER UNKNOWN FACTORS INCLUDE: INFUSION SET LOT NUMBER, PATIENT WEIGHT, CAUSE AND DIAGNOSIS OF THE STATE OF UNCONSCIOUSNESS, FAILURE (IF ANY) OF INFUSION SET(S) AND NUMBER OF INFUSION SETS INVOLVED. FINAL UNOMEDICAL CLINICAL EVALUATION: NOT ENOUGH INFORMATION AVAILABLE TO PERFORM A CLINICAL EVALUATION. THE CHAIN OF EVENTS IS NOT CLEAR. PATIENT HOSPITALIZATION DUE TO DIABETIC COMA (THE TERM REFERRING TO WHEN PHYSICIANS ARE CONFRONTED WITH UNCONSCIOUS PATIENTS ABOUT WHOM NOTHING IS KNOWN EXCEPT THAT PATIENT HAVE DIABETES). THE USED INFUSION SET HAS NOT BEEN RETURNED FOR TESTING AND IT IS NOT CLEAR WHETHER THIS INCIDENT IS ASSOCIATED WITH THE PUMP OR INFUSION SET. MORE INFORMATION IS NECESSARY.

    Description of Event or Problem · 1

    (B)(4). A DIABETIC, (B)(6) FEMALE PATIENT IS BEING TREATED WITH INSULIN VIA AN INSULIN PUMP AND A COMFORT INFUSION SET (MODEL 100-006-01). ON (B)(6) 2015 THE PATIENT IS REPORTED HOSPITALIZED FOR 'DIABETIC COMA' AFTER A 911 CALL. SHE IS TREATED BY HCPS. TREATMENT (AND OUTCOME) IS UNKNOWN. LEVELS OF BLOOD GLUCOSE AND KETONES ARE UNKNOWN. OTHER UNKNOWN FACTORS INCLUDE: INFUSION SET LOT NUMBER, PATIENT WEIGHT, CAUSE AND DIAGNOSIS OF THE STATE OF UNCONSCIOUSNESS, FAILURE (IF ANY) OF INFUSION SET(S) AND NUMBER OF INFUSION SETS INVOLVED. PRELIMINARY UNOMEDICAL CLINICAL EVALUATION: NOT ENOUGH INFORMATION AVAILABLE TO PERFORM A CLINICAL EVALUATION. THE CHAIN OF EVENTS IS NOT CLEAR. PATIENT HOSPITALIZATION DUE TO DIABETIC COMA (THE TERM REFERRING TO WHEN PHYSICIANS ARE CONFRONTED WITH UNCONSCIOUS PATIENTS ABOUT WHOM NOTHING IS KNOWN EXCEPT THAT PATIENT HAS DIABETES). THE USED INFUSION SET HAS NOT BEEN RETURNED FOR TESTING AND IT IS NOT CLEAR WHETHER THIS INCIDENT IS ASSOCIATED WITH THE PUMP OR INFUSION SET. MORE INFORMATION IS NECESSARY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750470 INFUSION SET COMFORT, MODEL 100-006-01 COMFORT FPA UNOMEDICAL A/S 100-006-01 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization