BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO FLEX METER

    MDR report key: 6833428 · Received August 31, 2017

    Report

    Report Number
    3008382007-2017-22372
    Event Type
    Injury
    Date Received
    August 31, 2017
    Report Date
    August 29, 2017
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    UDI-DI
    00353885010986
    PMA / PMN Number
    K150214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENTS METER AND TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. LIFESCAN ALSO CONDUCTED AN EVALUATION OF THE TEST STRIP LOT AND CONCLUDED THAT THIS LOT DID NOT BREACH THE THRESHOLDS SET FOR ESCALATION AND NO SYSTEMIC ISSUE WAS OBSERVED. ANALYSIS WAS NOT POSSIBLE FOR THE RETURNED TEST STRIPS DUE TO UNKNOWN STORAGE AND HANDLING PREVENTING THE ALLEGATION BEING PHYSICALLY INVESTIGATED. 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) 2017, THE PATIENT/LAY USER CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH VERIO FLEX METER READ INACCURATELY HIGH COMPARED TO ANOTHER METER AS WELL AS TO THEIR FEELINGS AND/OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY BEGAN AT 5:05AM ON (B)(6) 2017. AT THIS TIME THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF ¿200 MG/DL¿ WITH THE SUBJECT METER AND AN UNSPECIFIED RESULT ON ANOTHER METER WITHIN 30 MINUTES OF ONE ANOTHER. IN ADDITION, THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF ¿210, 195, 146, 183, 191, 197 AND 147 MG/DL¿ WITH THE SUBJECT METER WHICH THE PATIENT FELT WERE HIGHER THAN THEIR FEELINGS AND/OR NORMAL RESULTS. METER TO OTHER METER COMPARISONS DO NOT REASONABLY SUGGEST THAT A MALFUNCTION HAS OCCURRED. THERE CAN BE NO PRESUMPTION AS TO WHICH METER¿S READING IS ERRONEOUS AS THE COMPARISON IS NOT MADE TO A CALIBRATED REFERENCE METHOD. IN ADDITION, METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE THE POSSIBILITY OF INACCURACY. THE PATIENT MANAGES THEIR DIABETES WITH UNSPECIFIED DOSAGES OF ¿INSULIN AND PILLS¿ AND IN RESPONSE TO THE ALLEGED PRODUCT ISSUE A NON-HEALTHCARE PROFESSIONAL (HCP) GAVE THE PATIENT AN INCREASED DOSAGE OF INSULIN USING A NOVOLOG FLEXPEN AT 5:15AM ON (B)(6) 2017. THE PATIENT REPORTED THAT 30 MINUTES LATER THEY DEVELOPED THE SYMPTOM OF ¿SHAKY¿, AND WAS SUBSEQUENTLY GIVEN CHOCOLATE BY MEANS OF TREATMENT BY THE NON-HCP. THE PATIENT¿S BLOOD GLUCOSE WAS MEASURED 55 MINUTES LATER ON ANOTHER DEVICE AND A RESULT OF ¿107 MG/DL¿ WAS OBTAINED. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING. THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO WALK THROUGH A CONTROL SOLUTION TEST. THE PATIENT¿S PRODUCTS WERE REPLACED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT AFTER TAKING AN INCREASED DOSE OF INSULIN BASED ON ALLEGED INACCURATE HIGH RESULTS OBTAINED WITH THE SUBJECT METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615270 OT VERIO FLEX METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4225797 00353885010986

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening