BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3627774 · Received February 14, 2014

    Report

    Report Number
    2939301-2014-03643
    Event Type
    Injury
    Date Received
    February 14, 2014
    Report Date
    February 6, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (05/16/2014), 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. A DHR (DEVICE HISTORY RECORD) WAS DONE, AND COMPLETED ON 04/30/2014, ON THE SUBJECT METER LOT. THE DHR SHOWS THAT THE SUBJECT METER WAS REWORKED TO RESOLVE A SOFTWARE ISSUE RELATED TO THE VERIO RECALL (CORRECTION # 2013-IE-017) PRIOR TO BEING DISTRIBUTED. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. 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

    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) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH VERIOIQ METER READ INACCURATELY ERRATIC AND HIGH. 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) 2014. THE PATIENT REPORTED THAT ON (B)(6) 2014 AT APPROXIMATELY 8:45PM, HE OBTAINED A MESSAGE OF ¿EXTREME HIGH GLUCOSE¿ WITH THE SUBJECT METER. THIS WARNING APPEARS WHEN THE METER DETECTS A BLOOD GLUCOSE GREATER THAN 600 MG/DL. IN RESPONSE TO THE MESSAGE, THE PATIENT RETESTED HIS BLOOD GLUCOSE SEVERAL TIMES AND OBTAINED READINGS OF ¿403, 291, 211, 253, 198, 230 AND 195 MG/DL¿ PERFORMED WITHIN A 5 MINUTE PERIOD. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF LESS THAN OR EQUAL TO 20%. THE PATIENT MANAGES HIS DIABETES BY TAKING A SET DOSE OF LEVEMIR INSULIN TWICE A DAY (MORNING AND BEDTIME) AND ALSO TAKING HUMALOG INSULIN WITH MEALS (DOSE ADJUSTED BASED ON SLIDING SCALE). THE PATIENT CONFIRMED AFTER TESTING WITH THE SUBJECT METER ON THE EVENING OF (B)(6) 2014 HE TOOK HIS USUAL DOSE OF LEVEMIR INSULIN AND CALLED IN TO LFS THE FOLLOWING DAY REGARDING HIS CONCERN. DURING THE FOLLOW-UP CALL, THE PATIENT INFORMED THE MSS THAT ON TWO DIFFERENT OCCASIONS HE DEVELOPED SYMPTOMS HE ASSOCIATED WITH A LOW BLOOD GLUCOSE AFTER TAKING AN INCREASED DOSE OF INSULIN BASED ON ELEVATED RESULTS OBTAINED WITH THE SUBJECT METER. THE PATIENT COULD ONLY RECALL IT OCCURRED ONCE IN LATE (B)(6) 2014 AND AGAIN IN EARLY (B)(6) 2014. THE PATIENT REPORTED THAT ON THE TWO DIFFERENT DATES HE RECALLS TAKING APPROXIMATELY UP TO 10 ADDITIONAL UNITS OF HUMALOG INSULIN IN RESPONSE TO ELEVATED RESULTS OBTAINED WHEN HE TESTED (EXACT METER READINGS NOT RECALLED). THE PATIENT STATED THAT 1-1 ½ HOURS AFTER ADMINISTERING THE INSULIN HE FELT SWEATY, NAUSEOUS AND DEVELOPED A HEADACHE. AT THE ONSET OF SYMPTOMS HE CONFIRMED TESTING HIS BLOODGLUCOSE WITH THE SUBJECT METER AND OBTAINING READINGS IN THE ¿60¿S MG/DL¿. THE PATIENT CLAIMED HE WOULD TREAT SELF WITH GLUCOSE TABLETS IN RESPONSE TO SYMPTOMS AND CONFIRMED FEELING BETTER AFTERWARDS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED INACCURATE HIGH READINGS ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULTS, 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
    97096 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3530140

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R