BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUCOCARD 01 BLOOD GLUCOSE SYSTEM

    MDR report key: 3042816 · Received April 9, 2013

    Report

    Report Number
    1832816-2013-00030
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    PMA / PMN Number
    K073416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARKRAY ATTEMPTED TO GATHER INFORMATION AND REQUEST THE RETURN OF SUBJECT METER, BUT CUSTOMER REFUSED. ACTUAL PRODUCT WAS NOT RETURNED FOR TESTING. RETENTION SAMPLES OF THE SAME LOT OF TEST STRIPS INVOLVED IN THE INCIDENT WERE TESTED AND PERFORMED TO SPECIFICATION. CUSTOMER REFUSED TO SEND BACK.

    Description of Event or Problem · 1

    CALLER INDICATED THE GLUCOCARD 01 METER WAS READING HIGH. A VERY UPSET CUSTOMER SAID THAT SHE USED OUR METER FOR ABOUT A WEEK AND GOT HIGHER READINGS THAN NORMAL WHICH CAUSED HER TO TAKE ADDITIONAL METFORMIN. AFTER TAKING MEDICATION SHE FELT VERY DIZZY AND HAD TO LIE DOWN. SHE WOULD NOT GIVE A SPECIFIC TIME OR DATE OF ANY INCIDENT. SHE SAID THAT SHE CALLED MINI PHARMACY TO REPORT THIS INCIDENT AND THEY SENT HER A NEW METER BUT SHE IS VERY AFRAID TO USE THE METER BECAUSE SHE DOESN'T KNOW IF IT IS ACCURATE. SHE DID CONTROL SOLUTION ON BOTH THE OLD AND NEW METER AND BOTH TESTED IN RANGE INDICATING METER IS WORKING. SHE ALSO DID A BLOOD TEST WITH ME OVER THE PHONE ON THE NEW METER AND GOT READING OF 167. SHE FELT LIKE THAT WAS ACCURATE BUT SAID SHE WANTED TO TEST IT IN THE MORNING AGAIN AND WOULD CALL ME BACK IF THE READING WAS TOO HIGH. SHE REFUSED TO ANSWER MOST QUESTIONS ON THE INCIDENT REPORT FORM AND REFUSED TO DO TROUBLESHOOTING. SHE DID TELL ME THAT SHE WASHES HER HANDS AND USES AN ALCOHOL PAD BEFORE TESTING. SHE SAID THAT IF THE NEW METER IS INACCURATE SHE WILL BE CONTACTING HER LAWYER. I ASKED HER IF SHE WOULD LIKE US TO REPLACE ANYTHING AND SHE SAID NO. I ASKED HER TO SEND THE METER BACK TO US AND SHE SAID THAT SHE WILL NOT SEND ANYTHING BACK TO US. SHE REFUSED TO PROVIDE AN ADDRESS TO SEND A RETURN LABEL TO AND SAID THAT SHE WILL GIVE IT TO HER LAWYER OR THROW IT IN THE GARBAGE IF THE NEW METER IS GOOD. UNABLE TO REPLACE PRODUCT OR FOLLOW UP WITH CUSTOMER TO RETURN PRODUCT AND GATHER MORE INFORMATION AS SHE REFUSED TO GIVE PHONE NUMBER OR ADDRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146753 GLUCOCARD 01 BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 741100 E124A15

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening