BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3072749 · Received April 23, 2013

    Report

    Report Number
    3008382007-2013-08720
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    April 2, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH VERIO IQ METER WAS READING INACCURATELY HIGH COMPARED TO HER FEELING/ NORMAL RESULT(S). THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN IN THE MORNING ON (B)(6) 2013. AT UNSPECIFIED DATES/TIMES, THE PATIENT REPORTEDLY OBTAINED (WITH THE SUBJECT METER) BLOOD GLUCOSE READINGS OF "109, 113, 115, 126, 135, 138 143, 130, 174, 141, 151, 152, 169, 183, 228, 138, 156, 221, 242, 238, 208, 202, 224. 215, 170, 181, 133, 195, 177, 183, 200, 156,149, 140, 169, AND 159MG/DL." THE PATIENT DENIED TESTING HER BLOOD GLUCOSE WITH ANOTHER DEVICE. THE PATIENT MANAGES HER DIABETES WITH INSULIN (NO ADJUSTMENTS). ACCORDING TO THE CSR'S DOCUMENTATION FOR THE PAST THREE WEEKS (PRIOR TO GOING TO BED), THE PATIENT REPORTEDLY WOULD ADMINISTER AN ADDITIONAL 4 UNITS OF NOVOLOG WHEN HER BLOOD GLUCOSE READING EXCEEDED OVER 200MG/DL AND SUBSEQUENTLY, AT AN UNCLEAR TIME LATER THE PATIENT DEVELOPED A SYMPTOM OF SHAKING. THE PATIENT REPORTEDLY CONSUMED FOOD AND/OR DRINK AS SELF-TREATMENT (IN MID-(B)(6) AT 3AM). AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND NOTED THAT THE PATIENT PERFORMED A QUALITY CONTROL TEST THAT PASSED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY SUFFERED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173431 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3241895

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening| R