BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESTEP

    MDR report key: 169001 · Received May 22, 1998

    Report

    Report Number
    2939301-1998-00014
    Event Type
    Injury
    Date Received
    May 22, 1998
    Report Date
    April 23, 1998
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON APRIL 23, 1998 AT 6:30PM, THE PT WAS VISITED BY HIS GRANDDAUGHTER AND HER HUSBAND, WHO HAD BEEN INFORMED BY A NEIGHBOR THAT THE PT HAD NOT BEEN SEEN OR HEARD FROM FOR OVER A DAY. THE PT WAS FOUND FACE DOWN ON THE FLOOR, HE COULD TALK BUT COULD NOT MOVE HIS LEGS. THE GRANDDAUGHTER AND HER HUSBAND TESTED THE PT'S BLOOD GLUCOSE WITH A SURESTEP METER AND IT REGISTERED ER1. HE WAS SWEATING PROFUSELY, SO THE GRANDDAUGHTER GAVE HIM ORANGE JUICE. AT 7PM, THE GRANDDAUGHTER CALLED LIFESCAN CUSTOMER SERVICE AND SHE REPEATED THE BLOOD GLUCOSE TEST WHICH RESULTED IN ER1. THE LIFESCAN REPRESENTATIVE INSTRUCTED THE GRANDDAUGHTER TO COMPARE THE COLOR CONFIRMATION DOT ON THE SURESTEP TEST STRIP TO THE COLOR CODE ON THE TEST STRIP VIAL. THE COLOR WAS REPORTED TO BE DARKER THAN THE 350 MG/DL DOT AND "ALMOST BLACK." THE CUSTOMER SERVICE REPRESENTATIVE ADVISED THAT THIS INDICATED A BLOOD GLUCOSE LEVEL OF OVER 500 MG/DL AND THAT THE PT SHOULD BE TAKEN TO A DOCTOR IMMEDIATELY. A LIFESCAN TECHNICAL SERVICE REPRESENTATIVE SPOKE TO THE GRANDDAUGHTER SHORTLY THEREAFTER, AND A REPEAT GLUCOSE TEST REGISTERED ER1. THE GRANDDAUGHTER DROVE THE PT TO THE HOSPITAL. ON ARRIVING AT THE HOSPITAL AT 8PM, THE PT WAS TESTED WITH A ONE TOUCH METER WHICH REGISTERED "HI." AT ABOUT 9:30PM, A LABORATORY TEST INDICATED A BLOOD GLUCOSE LEVEL GREATER THAN 1200 MG/DL. THE PT WAS TREATED WITH A SLOW INTRAVENOUS DRIP AND INSULIN. THE GRANDDAUGHTER REPORTED THAT ON 4/14/1998, THE PT HAD RECEIVED A PRESCRIPTION FOR 400MG OF REZULIN AND HE STOPPED TAKING HIS INSULIN (IT IS NOT CLEAR IF CESSATION OF INSULIN WAS BASED UPON PHYSICIAN ADVICE). PRIOR TO THE CHANGE IN PRESCRIPTION, THE PT WAS RECEIVING 28U 70/30 INSULIN IN THE AM AND 10U 70/30 IN THE PM. THE GRANDDAUGHTER REPORTED THAT THE PT TESTS INFREQUENTLY, ONLY WHEN HE SENSES SOMETHING WRONG ( THE PT BEGAN USING THE METER IN JANUARY, 1998). SHE PROVIDED THE FOLLOWING RESULTS THAT WERE DISPLAYED IN THE METER MEMORY: ER1, ER6, 453, HI, 300, 131, ER3, 34, 160, 213. (NOTE CONSECUTIVE ERROR MESSAGES OF THE SAME TYPE ARE ONLY RECORDED IN ELECTRONIC METER MEMORY ONCE.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURESTEP BLOOD GLUCOSE MONITORING METER CGA LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R