BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 2488678 · Received March 12, 2012

    Report

    Report Number
    3008382007-2012-00717
    Event Type
    Injury
    Date Received
    March 12, 2012
    Date of Event
    March 3, 2012
    Report Date
    March 6, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    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. THE 510(K) # IS K110637.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT WHILE IN (B)(6), HIS ONETOUCH VERIO IQ CONTINUED TO PROMPT "APPLY BLOOD" AFTER A BLOOD SAMPLE HAD BEEN APPLIED TO THE TEST STRIP. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED MESSAGE APPEARED ON THE MORNING OF (B)(6) 2012 WHILE IN (B)(6). THE PATIENT CLAIMED HE ATTEMPTED TO TEST 7X; HOWEVER, THE SUBJECT METER CONTINUED TO PROMPT "APPLY BLOOD" AFTER HE HAD APPLIED BLOOD TO THE TEST STRIP. THE PATIENT REPORTED THAT AFTERNOON, HE RE-ATTEMPTED TO TEST AND ON BOTH OCCASIONS OBTAINED SAME MESSAGE. THE PATIENT INFORMED THE CSR THAT HE MANAGES HIS DIABETES WITH INSULIN. AS A RESULT OF NOT BEING ABLE TO TEST HIS BLOOD GLUCOSE LEVEL, THE PATIENT CLAIMED HE TOOK 10 UNITS OF INSULIN. THE PATIENT STATED HE GENERALLY TAKES ANYWHERE FROM 10 TO 16 UNITS. SHORTLY AFTER TAKING THE INSULIN, THE PATIENT REPORTED FEELING SHAKY, SWEATY AND LETHARGIC. IN RESPONSE TO THE SYMPTOMS, THE PATIENT CLAIMED HE TREATED HIMSELF WITH CANDY AND JUICE. AT THE TIME OF THE CALL, THE PATIENT INFORMED THE CSR THAT HE CONTACTED LFS (B)(4) ON THE DAY THE ISSUE BEGAN AND WHILE ON THE CALL, THE SUBJECT METER STARTED WORKING AND WAS ABLE TO TEST HIMSELF SUCCESSFULLY. THE PATIENT CLAIMED HE HAS BEEN ABLE TO CONTINUE TO USE THE SUBJECT METER WITHOUT FURTHER INCIDENCE SINCE HE CONTACTED LFS (B)(4). THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER HE WAS UNABLE TO TEST WITH THE SUBJECT METER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening| R