BEUDAMED
    FDA Adverse Event Death Summary report: N

    SILHOUETTE PARADIGM

    MDR report key: 1707029 · Received May 27, 2010

    Report

    Report Number
    8021545-2010-00004
    Event Type
    Death
    Date Received
    May 27, 2010
    Report Date
    May 27, 2010
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K002138
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE INVESTIGATION OF THE RETURNED UNUSED AND THE RETAINED SAMPLES WAS CONDUCTED WITHOUT IDENTIFYING ANY ANOMALIES ON THE INFUSION SETS WHICH COULD HAVE CONTRIBUTED TO THE EVENT. UNOMEDICAL CONSIDERS THE ROOT CAUSE OF THIS EVENT LACK OF TRAINING AND FAILURE TO FOLLOW THE INSTRUCTION FOR USE ACCOMPANYING THE DEVICE. IF THE INVOLVED DEVICE IS RETURNED FOR EVALUATION, A FOLLOW UP REPORT WITH THE RELEVANT FINDINGS WILL BE SUBMITTED. EVALUATION SUMMARY: THE INVOLVED DEVICE WAS NOT RETURNED FOR EVALUATION. USED DEVICE: NO USED SAMPLES WERE RETURNED FOR EVALUATION. UNUSED DEVICES: 8 UNUSED SAMPLES WERE RETURNED FOR EVALUATION. ALL 8 UNUSED SAMPLES WERE VISUALLY INSPECTED AND NO ANOMALIES WERE OBSERVED. FURTHERMORE A RE-CONNECTOR TEST, A FLOW TEST, A TEST FOR LEAKAGE AND A P-CAP VENT TEST WERE PERFORMED. ALL SAMPLES WERE FOUND TO BE WITHIN SPECIFICATIONS. REFERENCE SAMPLES: THE RETAINED SAMPLES WERE VISUALLY INSPECTED AND NO ANOMALIES WERE OBSERVED. FURTHERMORE A RE-CONNECTOR TEST, A FLOW TEST, A TEST FOR LEAKAGE AND A P-CAP VENT TEST WERE PERFORMED. ALL SAMPLES WERE FOUND TO BE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    PATIENT DECEASED, DUE TO LOW BG'S AND SEIZER. PATIENT WAS TAKEN TO RESURRECTION HOSPITAL AND TREATED FOR LOW BG. WIFE STATED THAT SHE WAS NOT SURE OF THE BG READING AT THE TIME OF PASSING. WIFE RETURNED THE PUMP TO MEDTRONIC MINIMED FOR ANALYSIS. FOR CONFIDENTIAL INFORMATION REGARDING THE END USER, (B) (6)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILHOUETTE PARADIGM FPA UNOMEDICAL A/S MMT-382 630782

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death