BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE PARADIGM

    MDR report key: 6921504 · Received October 6, 2017

    Report

    Report Number
    8021545-2017-00005
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    May 9, 2017
    Report Date
    October 5, 2017
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K162812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 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. 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.

    Description of Event or Problem · 1

    (B)(4). ON (B)(6) A FEMALE DIABETIC PATIENT EXPERIENCED A BLOOD GLUCOSE LEVEL OF 380 MG/DL, GAVE HERSELF A BOLUS AND WENT TO BED. SHE ALLEGEDLY DIED, WAS REVIVED AND SUFFERED BRAIN DAMAGE. HER BLOOD GLUCOSE LEVEL WAS ABOVE 1200 MG/DL AT THE TIME OF THE EVENT. SHE WAS ADMITTED TO (B)(6) HOSPITAL, AT THE ICU FOR 4 DAYS WITH THE DIAGNOSE OF DIABETIC KETOACIDOSIS AND SEPTISITUS. FURTHERMORE THE PATIENT DESCRIBED THAT ON THE LATEST OCCASION SHE HAD A BLOOD GLUCOSE LEVEL OF 600 MG/DL, WITH THE SYMPTOMS OF TIREDNESS, KIDNEY PAIN AND A SMALL AMOUNT OF KETONES. THE PATIENT WAS ABLE TO SELF TREAT THIS EPISODE. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702430 SILHOUETTE PARADIGM SILHOUETTE PARADIGM INSULIN INFUSION SET FPA UNOMEDICAL A/S UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L