BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION PCX

    MDR report key: 814115 · Received February 5, 2007

    Report

    Report Number
    2954323-2007-01510
    Event Type
    Death
    Date Received
    February 5, 2007
    Date of Event
    January 7, 2007
    Report Date
    February 5, 2007
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONFIRMED THAT THE ICU HAD NOT RUN ANY QC CONTROLS DURING THE NIGHT OF THE INCIDENT. IT WAS ALSO NOTED THAT THE I-STAT APPEARED TO BE CALIBRATED TO THE WRONG LOT OF STRIPS. ANOTHER COMPARISON TEST WAS PERFORMED ON A HITACHI INSTRUMENT AND A BLOOD GLUCOSE RESULT OF 8.6 MMOL/L WAS GENERATED. THE I-STAT GENERATED A BLOOD GLUCOSE RESULT OF 18.3 MMOL/L AND AN ALTERNATE METHOD (ISE) GENERATED A 13.3 MMOL/L RESULT. AN ABBOTT DIABETES CARE REP WILL BE VISITING THE HOSP AND DOING FURTHER INVESTIGATION AS TO THE CAUSE OF THE ISSUE. ADDITIONALLY, TEST STRIPS WITH LOT NUMBER 178015 WERE RETURNED TO ABBOTT DIABETES CARE. CONTROL SOLUTION TESTING WAS PERFORMED, AND ALL RESULTS WERE WITHIN RANGE. TEST STRIPS PERFORMED WITHIN SPECIFICATION AND NO ERRORS OR NEW ISSUES WERE OBSERVED DURING TESTING.

    Description of Event or Problem · 1

    A HOSP ICU REPORTED AN INCIDENT OF HYPOGLYCEMIA RELATED TO INSULIN TREATMENT GIVEN IN RESPONSE TO BLOOD GLUCOSE RESULTS GENERATED BY AN I-STAT-1 METER AND PRECISION PCX TEST STRIPS. THE PT UNDERWENT A LAPAROTOMY ON 2007 AND WAS SENT TO THE ICU POST-OPERATIVELY. INSULIN TREATMENT WAS GIVEN TO THE PT IN RESPONSE TO BLOOD GLUCOSE RESULTS GENERATED BY THE I-STAT-1 METER AND PRECISION PCX TEST STRIPS. FOLLOWING THE TREATMENT, THE PT BECAME HYPOGLYCEMIC AND DEVELOPED NEUROLOGICAL COMPLICATIONS. THE PT SUBSEQUENTLY EXPIRED 6 DAYS LATER. REVIEW OF THE CLINICAL COURSE OF EVENTS REVEALED THAT ON THE EVENING OF LAPAROTOMY, THE PT HAD A BLOOD GLUCOSE RESULT OF 24.2 MMOL/L FROM THE I-STAT METER. THE PT WAS THEN GIVEN 8 UNITS OF LONG ACTING INSULIN. APPROX 1 HR AND 45 MINUTES LATER, A BLOOD GLUCOSE READING OF 14.3 MMOL/L WAS OBTAINED ON THAT PT WITH THE SAME METER. AT 3:50 AM, A BLOOD GLUCOSE RESULT OF 13.6 MMOL/L WAS OBTAINED, AND OVER THE COURSE OF THE NIGHT, THE PT WAS GIVEN ADD'L FAST ACTING INSULIN. AT 7:00 AM, A BLOOD GLUCOSE LEVEL OF 0.6 MMOL/L WAS OBTAINED FOR THAT PT FROM THE LABORATORY. ONE HOUR LATER, THE I-STAT GENERATED A BLOOD GLUCOSE RESULT OF 5.8 MMOL/L AT 9:00 AM, THE LABORATORY OBTAINED A BLOOD GLUCOSE RESULT OF 2.4 MMOL/L AND THE I-STAT METER GENERATED A RESULT OF 14.1 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION PCX GLUCOSE STRIPS NBW ABBOTT DIABETES CARE LIMITED UK NA 178015

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death