BEUDAMED
    FDA Adverse Event Injury Summary report: N

    010-411-01F SURESTEP

    MDR report key: 115159 · Received August 21, 1997

    Report

    Report Number
    2939301-1997-00059
    Event Type
    Injury
    Date Received
    August 21, 1997
    Date of Event
    July 22, 1997
    Report Date
    August 21, 1997
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CGA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CO HAS COMPLETED CO'S INVESTIGATION OF THE MDR INCIDENT LISTED ABOVE AND, AFTER TESTING THE DEVICE, CO HAS NOT BEEN ABLE TO VERIFY A DEVICE MALFUNCTION WHICH COULD HAVE CONTRIBUTED TO THIS EVENT. CO CONCLUDES THE ALLEGED INACCURATE RESULTS MAY HAVE BEEN DUE TO USER ERROR, TESTING WHILE IN A DEHYDRATED CONDITION, OR SOME UNK ANOMALY. AT THIS POINT CO'S INVESTIGATION OF THIS MATTER IS CLOSED.

    Description of Event or Problem · 1

    THE PT, A IDDM AND INSULIN PUMP USER, AWOKE NOT FEELING WELL ON 3/6. A 5/A FASTING BLOOD GLUCOSE RESULT ON HER SURESTEP METER WAS 52 MG/DL. SHE REPORTED THAT SHE USES HUMALOG INSULIN IN HER PUMP AT A PRE-SET BASAL RATE, HOWEVER, SHE BOLUSES HER INSULIN BASED ON CARBOHYDRATE INTAKE. SHE DID NOT BOLUS HER INSULIN AFTER OBTAINING THE 52 MG/DL RESULT. SHE ATE BREAKFAST AND RETESTED HER BS AT APPROXIMATELY 9/A, OBTAINING A ERROR 1 MESSAGE AND THEN A RESULT OF 56 MG/DL. AT THIS TIME, SHE REPORTED FEELING THIRSTY. THE PT CONSUMED LUNCH AT 2/P AND BOLUSED HER INSULIN, 3.5U OVER 1 HOUR. AT 5/P, SHE ATTEMPTED TO TEST ON HER METER. OBTAINING ERROR 1 RESULTS. BECAUSE SHE FELT NAUSEATED, SHE WENT TO THE HOSP WHERE AT 7/P, HER BLOOD GLUCOSE WAS 990 (METHOD UNKNOWN). SHE EXPERIENCED A MILD HEART ATTACK, WHICH ELEVATED HER BG TO 1000 AFTER ARRIVAL. SHE STATED, "I CAN'T REALLY FAULT THE METER, THEY TOLD ME THAT A HEART ATTACK WOULD SPIKE MY SUGAR UP HIGH IN 2 HOURS." THE PT WAS TREATED FOR DEHYDRATION, MILD MI AND BS REGULATION AND REMAINED HOSPITALIZED UNTIL 3/11. THE METER IS CLEANED ACCORDING TO MFR'S RECOMMEDATIONS, HOWEVER QUALITY CONTROL TESTS RESULTS ARE NOT PERFORMED REGULARLY. THE PT HAD A DIFFICULT TIME PERFORMING A CONTROL SOLUTION TEST ON THE TEST STRIPS IN QUESTION. METER CALIBRATION STATUS IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 010-411-01F SURESTEP BLOOD GLUCOSE MONITOR CGA LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R