BEUDAMED
    FDA Adverse Event Death Summary report: N

    FREESTYLE FLASH

    MDR report key: 791013 · Received December 7, 2006

    Report

    Report Number
    2954323-2006-01521
    Event Type
    Death
    Date Received
    December 7, 2006
    Date of Event
    August 3, 2006
    Report Date
    December 7, 2006
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    LFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ABBOTT DIABETES CARE HAS REQUESTED DR TO SPEAK WITH OUR MEDICAL PERSONNEL IN AN EFFORT TO GATHER MORE INFO REGARDING THIS INCIDENT. TO DATE, DR HAS NOT CONTACTED ABBOTT MEDICAL PERSONNEL. A FOLLOW-UP REPORT SHALL BE SUBMITTED IF FURTHER INFO IS OBTAINED. AT PRESENT, THE METER HAS NOT BEEN RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    ON 11/08/06, DR REPORTED TO AN ABBOTT DIABETES CARE (ADC) SALES REP THAT IN 2006, A DIABETIC PT HAD SYMPTOMS OF HYPOGLYCEMIA AND THE METER GAVE A READING THAT WAS HIGHER THAN THE PT FELT IT SHOULD BE. THE PT DID TAKE MEDICATION AT THAT TIME. IT WAS ALSO NOTED THAT AT SOME POINT AFTER THIS INCIDENT (TIME-FRAME UNKNOWN), THE PT PASSED AWAY. DR INFORMED THE ADC SALES REP THAT SHE HAD SPOKEN TO THE CORONER AND IT WAS DETERMINED BY THE CORONER THAT THE CAUSE OF DEATH WAS NOT RELATED TO THE ADC DEVICE. WHEN CONTACTED A SECOND TIME, DR COULD NOT CONFIRM HER EARLIER STATEMENT THAT THE CORONER DETERMINED THAT THE CAUSE OF DEATH WAS NOT RELATED TO THE ADC DEVICE. ON 11/14/2006, A SECOND ADC SALES REP WENT TO THE HOSPITAL, AND SPOKE WITH A PEDIATRIC NURSE TO GATHER MORE INFO REGARDING THE EVENT. THE NURSE RECALLED THAT LAST SUMMER A PEDIATRIC DIABETIC PT PASSED AWAY. THE NURSE STATED THAT THE DEATH HAD NOTHING TO DO WITH THE PT'S METER. NO FURTHER INFO AS TO THE CUSTOMER NOR THE METER IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FLASH BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death