BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 2925706 · Received January 22, 2013

    Report

    Report Number
    3008382007-2013-01318
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 12, 2013
    Report Date
    January 16, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER MET SPECIFICATION AND WAS FOUND TO FUNCTION PROPERLY. THE METER WAS TESTED AND THE COMPLAINT WAS NOT REPRODUCED. PA UNABLE TO PERFORM STRIP INVESTIGATION SINCE THE PATIENT DID NOT PROVIDE TEST STRIPS LOT #. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. TEST STRIP LOT #: NOT PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VERIO IQ METER WAS GIVING INACCURATELY HIGH READINGS. THE TECHNICAL SERVICE REPRESENTATIVE CONTACTED THE PATIENT TO OBTAIN AND VERIFY INFORMATION; HOWEVER, WAS UNABLE TO REACH HIM BY TELEPHONE. THE SR. MEDICAL SURVEILLANCE SPECIALIST CLASSIFIED THE COMPLAINT BASED ON THE INFORMATION INITIALLY PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2013, THE PATIENT CLAIMED TO BE EXPERIENCING "HYPOGLYCEMIC" SYMPTOMS; SPECIFIC SYMPTOMS NOT PROVIDED. WHILE SYMPTOMATIC, THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 165 MG/DL ON THE REPORTED METER, AND A READING OF 56 MG/DL ON ANOTHER MANUFACTURER'S METER WITHIN 30 MINUTES OF EACH OTHER. AFTERWARDS, THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING GLUCOSE TABLETS; HE DID NOT SEEK ANY MEDICAL ATTENTION. TROUBLESHOOTING REVEALED THE TEST STRIPS HAD BEEN STORED IMPROPERLY OUTSIDE OF THE CONTAINER PROVIDED, WHICH CAN CAUSE INACCURATE READINGS. IT WAS ALSO DETERMINED THE PATIENT'S TESTING TECHNIQUE WAS INCORRECT. IT WOULD HAVE BEEN HELPFUL TO DETERMINE THE PATIENT'S METER READINGS AND MEALS TAKEN PRIOR TO THE ONSET OF SYMPTOMS, IF HE FELT BETTER AFTER CONSUMING THE GLUCOSE, IF THE PATIENT SOUGHT ANY MEDICAL ATTENTION, AND HIS EXPECTED BLOOD GLUCOSE READINGS. THE METER AND TEST STRIPS WERE REPLACED. THE PATIENT'S TECHNIQUE WAS INCORRECT AND THE TEST STRIPS WERE COMPROMISED BY IMPROPER STORAGE AND HANDLING. THE PATIENT'S STATUS, ACTIONS AND BLOOD GLUCOSE READINGS PRIOR TO THE ONSET OF SYMPTOMS WERE NOT KNOWN. HOWEVER, AS THE PATIENT ALLEGEDLY SUFFERED BLOOD GLUCOSE READINGS AND SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA WHILE USING THE REPORTED METER AND TEST STRIPS, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30571 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening