BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3217213 · Received July 10, 2013

    Report

    Report Number
    3008382007-2013-19275
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 13, 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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 HIS ONETOUCH VERIOIQ METER READ INACCURATELY LOW. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) DURING A FOLLOW-UP CALL WITH THE PATIENT ON (B)(6) 2013. THE PATIENT REPORTED THAT ON (B)(6) 2013, WHILE IN THE ER HE OBTAINED BLOOD GLUCOSE READINGS OF ¿400¿S MG/DL¿ WITH THE SUBJECT METER AND ¿690 MG/DL¿ ON A LABORATORY DEVICE, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF LESS THAN OR EQUAL TO 20%. THE PATIENT STATED THAT HE WENT TO THE EMERGENCY ROOM BECAUSE HE HAD NOT BEEN FEELING WELL AND WHEN HE TESTED HIS BLOOD PRESSURE AT HOME IT WAS HIGH (170/106). THE PATIENT STATED THAT FOR 2 OR 3 DAYS PRIOR TO (B)(6) 2013, HE HAD BEEN FEELING DIZZY, HAD A HEADACHE AND FELT DEHYDRATED. THE PATIENT REPORTED THAT HE WAS TREATED WITH 3 BAGS OF SALINE IN RESPONSE TO HIS HIGH BLOOD GLUCOSE AND WAS KEPT OVERNIGHT FOR OBSERVATION. THE PATIENT REPORTED THAT HE DID NOT RECEIVE ANY TREATMENT FOR ANY OTHER HEALTH CONDITION. THE PATIENT REPORTED THAT ON (B)(6) 2013, PRIOR TO GOING TO THE ER, HE OBTAINED READINGS IN THE ¿400¿S MG/DL¿ RANGE. HOWEVER, PRIOR TO (B)(6) 2013, THE PATIENT CLAIMED HE WAS OBTAINING READINGS IN THE ¿100¿S TO 200 MG/DL¿ RANGE. THE PATIENT WAS MANAGING HIS DIABETES WITH LANTUS (SET DOSE) AND NOVOLOG (ADJUSTED BASED ON SLIDING SCALE) IN THAT TIME PERIOD. THE PATIENT CLAIMED HE ADJUSTED HIS INSULIN DOSE BASED ON METER READINGS AND CARBOHYDRATE INTAKE. THE PATIENT FELT THAT THE HIGH BLOOD GLUCOSE EXCURSION MAY HAVE BEEN AS A RESULT OF NOT ADMINISTERING ENOUGH INSULIN DUE TO THE INACCURATE LOW READINGS HE WAS OBTAINING WITH THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED INACCURATE LOW READINGS ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULTS, AND REPORTEDLY DEVELOPED SIGNS/SYMPTOMS OF HYPERGLYCEMIA AFTER THE ALLEGED METER INACCURACY BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317545 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3387172

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| L| R