BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO PRO METER

    MDR report key: 3131893 · Received May 29, 2013

    Report

    Report Number
    3008382007-2013-13171
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Removal / Correction Number
    2013-IE-017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 (B)(4) 2013: ON (B)(6) 2013 THE LAY USER/PATIENT WAS CONTACTED BY LIFESCAN (LFS) (B)(4) TO FOLLOW UP ON AN "UNKNOWN" ISSUE. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY A CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW-UP CALL ON (B)(6) 2013. THE ALERT DATE SHOULD BE BASED ON THE DATE THAT THE ADVERSE EVENT WAS REPORTED ((B)(6) 2013) NOT (B)(6) AS ORIGINALLY REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT¿S MOTHER CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT THE PATIENT¿S ONETOUCH VERIOPRO METER WAS READING INACCURATELY LOW. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY A CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW-UP CALL. THE REPORTER CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2013 AT AN UNKNOWN TIME. THE PATIENT REPORTEDLY TESTED ON THE SUBJECT METER AND OBSERVED A VALUE OF ¿24MG/DL.¿ IT IS NOT KNOWN HOW THE PATIENT MANAGES HIS DIABETES. BASED ON THE METER RESULT THE PATIENT REPORTEDLY CONSUMED SUGAR AND BISCUITS AT AN UNKNOWN TIME. IT IS NOT KNOWN IF THE PATIENT WAS EXPERIENCING SYMPTOMS OF LOW BLOOD GLUCOSE AT THE TIME. THE REPORTER STATED THAT THE PATIENT CONTINUED WITH THIS TREATMENT OF FOOD AND SUGAR ON (B)(6) AND (B)(6), HOWEVER, SHE COULD NOT RECALL WHAT THE PATIENT¿S BLOOD GLUCOSE READINGS WERE DURING THIS TIME PERIOD. ON AN UNKNOWN DATE, WITHIN THIS TIMEFRAME, SHE CLAIMED THAT THE PATIENT BEGAN VOMITING. HE TESTED WITH THE SUBJECT METER AND OBSERVED A ¿VERY HIGH¿ RESULT (UNKNOWN VALUE). THE REPORTER CLAIMED THAT ON (B)(6) 2013 IN THE MORNING (TIME UNKNOWN) THE PATIENT WENT INTO ¿DIABETIC COMA.¿ HE WAS TAKEN TO THE HOSPITAL THAT SAME DAY AND WAS ADMITTED FOR THREE DAYS. THE REPORTER DID NOT HAVE ANY ADDITIONAL INFORMATION REGARDING BLOOD GLUCOSE RESULTS OR TYPE OF TREATMENT RECEIVED WHILE IN THE HOSPITAL. THE REPORTER STATED, SHE DOESN'T KNOW WHAT CAUSED THE PATIENT'S ALLEGED INJURY. IT IS NOT CONFIRMED WHAT THE METER¿S UNIT OF MEASUREMENT WAS AT THE TIME OF TESTING. NOR IS IT KNOWN WHETHER THE PATIENT WAS PERFORMING THE TESTING ACCORDING TO THE INSTRUCTIONS IN THE OWNER¿S MANUAL. BASED ON THE INFORMATION PROVIDED, IT IS NOT CLEAR IF THE METER CAUSED/CONTRIBUTED TO THE SERIOUS INJURY DUE TO THE LACK OF INFORMATION PROVIDED. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE, THE REPORTER ALLEGED THAT THE PATIENT SELF TREATED WITH FOOD/DRINK BASED ON AN INACCURATE LOW BLOOD GLUCOSE READING(S) AND AS A RESULT DEVELOPED SYMPTOMS OF SEVERE HYPERGLYCEMIA THAT REQUIRED MEDICAL TREATMENT BY AN HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235904 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3270030

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| L| R