BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3904102 · Received July 1, 2014

    Report

    Report Number
    2939301-2014-16036
    Event Type
    Injury
    Date Received
    July 1, 2014
    Report Date
    June 23, 2014
    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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (07/18/2014).THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON 7/9/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 7/9/2014 WITH THE FOLLOWING FINDINGS:THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 ¿ (08/26/2014). THE PATIENT¿S METER HAS BEEN RETURNED ON (B)(4) 2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ((B)(4)) ALLEGING THAT HIS ONETOUCH VERIO IQ METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY A CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW-UP CALL. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON AN UNKNOWN DATE/TIME APPROXIMATELY 2-3 WEEKS AGO. THE PATIENT REPORTED TESTING ON THE SUBJECT METER AT 7PM AND OBTAINING A READING BETWEEN ¿180MG/DL -210MG/DL.¿ EXACT READING IS UNKNOWN. THE PATIENT MANAGES HIS DIABETES WITH SLIDING-SCALE HUMALOG INSULIN BASED ON METER READINGS AND ¿PROTIFARME¿ (LONG ACTING INSULIN), 42 UNITS AT 10PM EVERY EVENING AND TESTS HIS BLOOD 4X PER DAY. THE PATIENT REPORTEDLY ADMINISTERED 22 OR 23 UNITS OF HUMALOG INSULIN IN RESPONSE TO THE ALLEGED HIGH READING. APPROXIMATELY 45 MINUTES TO 1 HOUR LATER, HE REPORTEDLY DEVELOPED SYMPTOMS OF ¿SHAKING, SWEATING AND FLICKERING IN THE EYES.¿ THE PATIENT RE-TESTED ON THE SUBJECT DEVICE AND OBSERVED A VALUE OF ¿40MG/DL.¿ HE IMMEDIATELY SELF-TREATED HIS SYMPTOMS BY DRINKING AN APPLE JUICE SPRITZER AT APPROXIMATELY 8PM. THE PATIENT REPORTED THAT HE BEGAN TO FEEL MUCH BETTER APPROXIMATELY 1 HOUR LATER. HE REPORTED THAT HE RETESTED AT 8:30PM ON THE SUBJECT METER AND OBSERVED A READING OF ¿80MG/DL.¿ HIS BLOOD GLUCOSE VALUES RETURNED TO A NORMAL OF ¿130MG/DL¿ AT APPROXIMATELY 9PM. THE PATIENT CONTINUED WITH HIS USUAL DOSE OF PROTIFARME INSULIN AT 10PM. NO OTHER DEVICE WAS USED FOR TESTING AT THIS TIME. THE PATIENT REPORTED THAT HE COMPARED HIS METER READING TO HIS DOCTOR¿S METER APPROXIMATELY 6 WEEKS EARLIER. HE RECEIVED A READING OF ¿180MG/DL¿ AND HIS DOCTOR¿S METER (UNKNOWN BRAND) READ ¿165MG/DL.¿ THE TESTS WERE PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS FALLS WITHIN THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. NO OTHER DEVICE WAS USED FOR TESTING AT THIS TIME. THE PATIENT REPORTED THAT HE COMPARED HIS METER READING TO HIS DOCTOR¿S METER APPROXIMATELY 6 WEEKS EARLIER. HE RECEIVED A READING OF ¿180MG/DL¿ AND HIS DOCTOR¿S METER (UNKNOWN BRAND) READ ¿165MG/DL.¿ THE TESTS WERE PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS FALLS WITHIN THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. NO TREATMENT WAS PROVIDED AT THIS TIME. AT THE TIME OF TROUBLESHOOTING THE CSR CONFIRMED THE METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE SAMPLES WERE OBTAINED FROM THE SAME APPROVED SAMPLE SITE. A CONTROL SOLUTION TEST WAS NOT PERFORMED BECAUSE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION TEST AVAILABLE. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT CLAIMS HE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382118 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3620646

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening| R