BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 2800444 · Received October 22, 2012

    Report

    Report Number
    3008382007-2012-05380
    Event Type
    Injury
    Date Received
    October 22, 2012
    Report Date
    September 27, 2012
    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
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER RETURNED 1 VIAL LOT# 3324067 AND 1 VIAL LOT# 3332828. BOTH VIALS RETURNED EMPTY, UNABLE TO PERFORM STRIP PA. LIFESCAN (LFS) HAS REQUESTED THE RETURN OF THE METER FOR EVALUATION. IF THE METER IS RETURNED LFS WILL EVALUATE IT AND INFORM FDA OF THOSE FINDINGS IN A SUPPLEMENTAL REPORT. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT IN THE UNITED KINGDOM CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH VERIOIQ METER WAS DISPLAYING A MESSAGE TO RETEST. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED FROM THE PATIENT DURING A FOLLOW-UP CALL BY A CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT TEST FIVE TIMES A DAY AND MANAGES HER DIABETES WITH NOVORAPID (1.5 UNITS PER 10 GRAMS DURING BREAKFAST AND 1 UNIT PER 10 GRAMS DURING LUNCHTIME) AND LEVIMIR (DOSAGE NOT SPECIFIED). THE PATIENT'S TARGET RANGE IS BETWEEN "6-9MMO/L." IT IS NOT KNOWN WHEN THE ALLEGED ISSUE FIRST BEGAN AND THE PATIENT DOES NOT RECALL WHAT ACTION SHE TOOK IN RESPONSE TO THE ALLEGED METER ISSUE. THE PATIENT'S PREVIOUS BLOOD GLUCOSE READING, PRIOR TO THE START OF THE ALLEGED ISSUE, IS NOT KNOWN. THE PATIENT DOES NOT RECALL IF SHE DEVELOPED ANY SYMPTOM(S) AS A RESULT OF THE REPORTED ISSUE. AT AN UNKNOWN DATE/TIME AFTER THE PRODUCT ISSUE OCCURRED, THE PATIENT CLAIMED SHE TESTED HER BLOOD GLUCOSE WITH ANOTHER DEVICE AND OBTAINED A READING OVER "30MMOL/L" AND IN RESPONSE TO THE RESULT, THE PATIENT INDICATED SHE SELF ADMINISTERED A "HUGE AMOUNT OF INSULIN." ACCORDING TO THE PATIENT, WHEN HER BLOOD GLUCOSE IS AROUND "30MMOL/L," SHE WOULD ADMINISTER AND ADDITIONAL 7 UNITS OF NOVORAPID INSULIN TO BRING IT DOWN TO 9MMOL/L; AND IF AFTER TWO HOURS HER BLOOD GLUCOSE IS STILL HIGH, SHE WOULD ADMINISTER AN ADDITIONAL 7 UNITS OF INSULIN. DURING TROUBLESHOOTING, THE CSR VERIFIED THE PATIENT WAS NOT USING THE SUBJECT METER FOR THE FIRST TIME AND THERE WAS NO MISUSE OF THE LFS PRODUCT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE ALLEGED METER ISSUE AND AT AN UNKNOWN TIME LATER SHE REPORTEDLY OBTAINED A READING OVER "30MMOL/L" WITH ANOTHER DEVICE AFTER THE ALLEGED METER ISSUE OCCURRED.

    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 3324067

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R