BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 1890339 · Received November 3, 2010

    Report

    Report Number
    2954323-2010-01520
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    October 7, 2010
    Report Date
    December 6, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: DURING THE COURSE OF THE TROUBLESHOOTING SURVEY THE CUSTOMER REPORTED SHE WAS ABLE TO SUCCESSFULLY TEST WHILE TALKING ON THE TELEPHONE WITH ADC CUSTOMER SERVICE.

    Additional Manufacturer Narrative · 1

    CUSTOMER'S METER AND TEST STRIPS WERE RETURNED FOR INVESTIGATION. THE COMPLAINT WAS NOT CONFIRMED. METER POWERED ON WITH BUTTON AND INSERTION OF CALIBRATION BAR. METER ALSO POWERED ON WITH INSERTION OF STRIPS. DID NOT OBSERVE POWER ISSUE WITH STRIP PORT. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6), 2010, A CUSTOMER REPORTED HER PRECISION XTRA BLOOD GLUCOSE METER WOULD TURN ON WITH THE BUTTON, BUT NOT WHEN A TEST STRIP WAS INSERTED INTO THE PORT. THE CUSTOMER ALSO REPORTED THAT AFTER USING ABOUT FIVE OR SIX TEST STRIPS THE METER WOULD TURN ON AND THIS ISSUE OCCURRED FOR APPROXIMATELY ONE TO TWO WEEKS. AS A RESULT, THE CUSTOMER WAS REPORTEDLY UNABLE TO KNOW HER BLOOD GLUCOSE LEVEL AND THOUGHT SHE MIGHT HAVE SORES DUE TO THAT ISSUE. THE CUSTOMER REPORTED SHE EXPERIENCED SYMPTOMS OF HYPOGLYCEMIA (TREMULOUSNESS, DIZZINESS, WEAKNESS) AND HYPERGLYCEMIA (DIABETIC SORES). THE CUSTOMER WAS REPORTEDLY SEEN BY A DOCTOR WHO DIAGNOSED HER WITH HYPERGLYCEMIA AND THE ONLY TREATMENT RENDERED WAS THE APPLICATION OF AN UNKNOWN CREAM TO HER SORES. THE CUSTOMER FURTHER REPORTED SHE TOOK HER REGULAR DIABETES MEDICATIONS (GLIPIZIDE AND METFORMIN) AND THIS WAS NOT A CHANGE TO HER NORMAL SELF-TREATMENT. ADDITIONALLY, THE CUSTOMER REPORTED SHE ATE CANDY TO ALLEVIATE HER SYMPTOMS. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE UNIT POWERS OFF DURING USE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 45001A641

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention