BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3121254 · Received May 20, 2013

    Report

    Report Number
    3008382007-2013-12177
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Report Date
    April 23, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 (05/28/2013): ON (B)(6), 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4) AND SPOKE WITH A CUSTOMER CARE ADVOCATE (CCA) PROVIDING ADDITIONAL INFORMATION REGARDING THIS COMPLAINT. THE PATIENT TESTS HER BLOOD GLUCOSE 2-4X DAILY AND HER EXPECTED RESULTS ARE USUALLY BETWEEN ¿7-9 MMOL/L.¿ THE PATIENT MANAGES HER DIABETES WITH HUMALOG INSULIN (11 UNITS 3X DAILY WITH MEALS) AND LANTUS INSULIN (42 UNITS 1X BEFORE BED). THE ALLEGED ISSUE BEGAN AROUND 330AM; HOWEVER, THE PATIENT COULD NOT SPECIFY THE DATE. PRIOR TO COMPARING METERS, THE PATIENT CLAIMED SHE WOKE UP FEELING A SYMPTOM OF EXCESSIVE PERSPIRATION. THE PATIENT ATE AN ORANGE AND SOME YOGURT AS TREATMENT. THE PATIENT COULD NOT SPECIFY RESULTS OBTAINED PRIOR TO EXPERIENCING SYMPTOMS; HOWEVER, DENIED MAKING CHANGES TO HER USUAL MANAGEMENT ROUTINE. THIS COMPLAINT IS STILL BEING REPORTED BECAUSE THE SUBJECT METER DID NOT MEET LFS¿ ACCURACY CRITERIA.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING HER ONETOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE CUSTOMER CARE ADVOCATE (CCA) WAS UNABLE TO REACH THE LAY USER/ PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LIFESCAN CUSTOMER SERVICE. THE ALLEGED ISSUE BEGAN ON (B)(6) 2013. HE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF ¿13 MMOL/L¿ WITH THE SUBJECT METER AND ¿3.1 MMOL/L¿ ON ANOTHER METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 1.7 MMOL/L. IT IS NOT KNOWN HOW THE PATIENT MANAGES HER DIABETES OR IF CHANGES WERE MADE TO HER USUAL MANAGEMENT ROUTINE. PRIOR TO TESTING, THE PATIENT CLAIMED SHE WAS ¿ALREADY FEELING LOW.¿ SPECIFIC SYMPTOMS WERE NOT PROVIDED. NO TREATMENT WAS SPECIFIED. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM QUALITY CONTROL TESTING. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT¿S SYMPTOMS STARTED BEFORE THE REPORTED ISSUE FIRST OCCURRED. THERE WAS NO INDICATION THAT THE PATIENT¿S SYMPTOMS DETERIORATED SINCE THE PATIENT DID NOT RECEIVE ANY FORM OF MEDICAL INTERVENTION AFTER THE PRODUCT ISSUE OCCURRED. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE SUBJECT METER DID NOT MEET LFS¿ ACCURACY CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222293 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR