BEUDAMED
    FDA Adverse Event Death Summary report: N

    SILHOUETTE PARADIGM

    MDR report key: 2525546 · Received April 5, 2012

    Report

    Report Number
    8021545-2012-00001
    Event Type
    Death
    Date Received
    April 5, 2012
    Date of Event
    February 6, 2012
    Report Date
    April 3, 2012
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPK
    PMA / PMN Number
    K002138
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UNOMEDICAL WAS, BY OUR DISTRIBUTOR, MADE AWARE OF THE DEATH OF A PATIENT. NO DEVICES WERE SHIPPED TO UNOMEDICAL AND SINCE NO LOT NUMBER WAS AVAILABLE, THE RETAINED SAMPLES FROM THE RESERVE LOT COULD NOT BE TESTED. THE DEATH CASE WAS REPORTED AS MASSIVE STROKE. THE 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.

    Description of Event or Problem · 1

    NAME OF DECEASED CUSTOMER: (B)(6). DATE OF DEATH: (B)(6) 2012. CALLER WAS OFF THE PUMP THERAPY IN HOSPITAL. DOCUMENT DATE OF LAST BG RECORDED IN METER OR PUMP: 387. NAME OF THE CALLER/REPORTER NAME: (B)(6). CALLER'S RELATIONSHIP TO THE DECEASED: SISTER. WHAT LED UP TO THE EVENT? CALLER STATES THAT HER SISTER WAS SICK AND DID NOT GO TO WORK. HER CO-WORKERS BECAME CONCERNED AND CALLED EMS. CALLER STATES DUE TO HER SISTER FEELING SICK SHE DID NOT TAKE MEDICINE THROUGHOUT THE DAY. CALLER STATES THAT SHE POSSIBLY WAS EXPERIENCING MINI-STROKES THROUGHOUT THE DAY. SHE HAD HIGH BG OF 387 AND HIGH BLOOD PRESSURE AT TIME OF CALL TO EMS. CALLER STATES THAT PUMP IS CURRENTLY IN (B)(6) LANGUAGE. UNSURE IF THIS WAS CHANGED AT THE HOSPITAL OR WAS IN THIS LANGUAGE WITH CUSTOMER. MASSIVE STROKE PATIENT WAS NOT WEARING PUMP AT THE TIME OF DEATH. THE PUMP WAS REMOVED WHEN SHE WENT TO THE HOSPITAL ON (B)(6) 2012. HOSPITAL IS: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILHOUETTE PARADIGM INFUSION SET FPK UNOMEDICAL A/S MMT-381 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death