BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE PRECISION H

    MDR report key: 3191622 · Received June 26, 2013

    Report

    Report Number
    2954323-2013-00354
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 29, 2013
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HOWEVER, A RECENT UPDATE REGARDING THE STATUS OF THE PATIENT REVEALED THE PATIENT HAD BEEN RELEASED FROM THE INTENSIVE CARE UNIT AND WAS TRANSFERRED TO THE GENERAL WARD. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT. THIS IS A FINAL REPORT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. THE METER HAS BEEN RETURNED AND AN INVESTIGATION UTILIZING THE RETURNED METER, RETURNED TEST STRIPS AND RETAINED CONTROL SOLUTION (LOT NO: MGK20625) HAS DETERMINED THE COMPLAINT IS NOT CONFIRMED. ALL RESULTS WERE WITHIN RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. ADDITIONALLY, IT SHOULD BE NOTED: LABEL COPY INSTRUCTS END USERS THAT TEST RESULTS MAY BE ERRONEOUSLY LOW IF THE PATIENT IS SEVERELY DEHYDRATED, SEVERELY HYPOTENSIVE, IN SHOCK OR IN A HYPERGLYCEMIC-HYPEROSMOLAR STATE (WITH OR WITHOUT KETOSIS).

    Description of Event or Problem · 1

    A PARAMEDIC REPORTED THAT ON (B)(6) 2013 THEY WERE CALLED TO ASSIST A CUSTOMER WHO WAS UNCONSCIOUS. UPON ARRIVAL THEY PERFORMED A GLUCOSE TEST USING THEIR ADC BLOOD GLUCOSE METER AND RECEIVED A READING OF 2.4 MMOL/L (43 MG/DL) AT 19:49. AN INTRAVENOUS INFUSION OF D10W 100 ML. WAS INITIATED AT 19:55 AND INFUSED AT "FULL RATE". A SECOND GLUCOSE TEST WAS PERFORMED AT 19:58 AND A READING OF "HI" (A READING GREATER THAN 28 MMOL/L OR 500 MG/DL) WAS RECEIVED. IT WAS FURTHER REPORTED THAT BETWEEN 19:58 AND 20:00 A TOTAL OF TWO INFUSIONS OF D10W 100 ML WAS INFUSED INTO THE CUSTOMER, BUT IT IS UNKNOWN WHEN THE SECOND INFUSION WAS STARTED. AT 20:00 A THIRD GLUCOSE TEST WAS PERFORMED AND A READING OF "LO" (A READING LESS THAN 1.1 MMOL/L OR 20 MG/DL) WAS RECEIVED. CUSTOMER WAS TRANSPORTED TO A LOCAL HOSPITAL AND ARRIVED AT 20:17. AT THE HOSPITAL A GLUCOSE TEST WAS PERFORMED USING THE HOSPITAL'S PRECISION EXCEED PRO METER, BUT THAT RESULTED IN AN ERROR MESSAGE. AFTER APPROXIMATELY 20 MINUTES ANOTHER GLUCOSE TEST WAS PERFORMED AT 20:43 USING THE HOSPITAL'S PXP METER AND THE RESULT WAS "HI". A HOSPITAL LABORATORY "SPOT SUGAR" WAS OBTAINED WITH A RESULT OF 80.1 MMOL/L (1443 MG/DL), BUT IT IS UNKNOWN WHEN THIS RESULT WAS OBTAINED RELATIVE TO THE OTHER BLOOD GLUCOSE RESULTS. IT IS UNKNOWN WHAT DIAGNOSIS THE CUSTOMER WAS GIVEN OR WHAT TREATMENT MAY HAVE BEEN RENDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290064 FREESTYLE PRECISION H BLOOD GLUCOSE MONITORING TEST STRIPS NBW 49506

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R