BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 2801343 · Received October 23, 2012

    Report

    Report Number
    3008382007-2012-05419
    Event Type
    Injury
    Date Received
    October 23, 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 CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH VERIOIQ METER WAS READING INACCURATELY LOW COMPARED TO HER FEELING. 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." ACCORDING TO THE PATIENT, SHE DOES NOT KNOW WHEN THE ALLEGED ISSUE BEGAN, SHE DOES NOT RECALL WHAT HER BLOOD GLUCOSE READING WAS AT THE TIME THE ALLEGED ISSUE OCCURRED, NOR DOES SHE RECALL WHAT ACTION SHE TOOK IN RESPONSE TO THE ALLEGED ISSUE. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT CONFIRMED SHE DEVELOPED SYMPTOMS OF KETONES, SEMI-CONSCIOUSNESS, CONFUSION, VOMITING, HEADACHE, LOSS OF APPETITE, AND SHE BEGAN SPEAKING IN DANISH. ACCORDING TO THE PATIENT, SINCE SHE WAS SEMI-CONSCIOUS HER SON WAS TAKING CARE OF HER; HER BLOOD GLUCOSE READING (WITH THE SUBJECT METER) AT THE ONSET OF HER SYMPTOMS IS NOT KNOWN AND SHE IS NOT AWARE IF HER SON RE-TESTED HER BLOOD GLUCOSE WITH THE SUBJECT METER AFTER HER SYMPTOMS BEGAN. AT AN UNSPECIFIED DATE/TIME AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT CLAIMED SHE HAD ADMINISTERED A "HUGE AMOUNT OF INSULIN." THE PATIENT CLARIFIED THAT IF HER BLOOD GLUCOSE RESULT IS AROUND "30MMOL/L" SHE WOULD ADMINISTERED AN ADDITIONAL 7 UNITS OF NOVORAPID INSULIN IN ORDER TO BRING HER BLOOD GLUCOSE DOWN TO "9MMOL/L," RETEST TWO HOURS LATER, AND IF HER BLOOD GLUCOSE IS STILL ELEVATED SHE WOULD ADMINISTERS AND ADDITIONAL 7 UNITS OF INSULIN; THE PATIENT'S BLOOD GLUCOSE READING WITH THE SUBJECT METER, PRIOR TO ADMINISTERING THE INSULIN IS NOT CLEAR. THE PATIENT INDICATED HER SYMPTOMS IMPROVED THE FOLLOWING DAY. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH A SERIOUS INJURY AFTER THE ALLEGED ISSUE BEGAN.

    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