BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3855101 · Received June 9, 2014

    Report

    Report Number
    2939301-2014-13798
    Event Type
    Injury
    Date Received
    June 9, 2014
    Report Date
    June 4, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ ((B)(6) 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 COMPLETED ON (B)(4) 2014 FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. 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 PHARMACIST/REPORTER CONTACTED LIFESCAN (LFS) (B)(4) ON BEHALF OF THE PATIENT, ALLEGING THAT THE ONETOUCH VERIOIQ METER IS GIVING INACCURATE HIGH READING RESULTS. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. ACCORDING TO THE REPORTER, THE PATIENT REQUIRED TREATMENT WITH INSULIN BASED ON THE ALLEGED HIGH READING RESULTS AND SUBSEQUENTLY DEVELOPED SYMPTOMS DESCRIBED AS ¿VERTIGO AND SWEATING." IT WOULD HAVE BEEN HELPFUL TO OBTAIN MORE INFORMATION ABOUT THE CIRCUMSTANCES SURROUNDING THE REPORTED INCIDENT; HOWEVER, THE REPORTER WAS NOT AVAILABLE FOR FOLLOW-UP INFORMATION. THE REPORTER CONFIRMED THAT TEST STRIPS WERE WITHIN THE DISCARD DATE DURING TROUBLESHOOTING. THE UNIT OF MEASUREMENT WAS WITHIN THE DISCARD DATE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT HAD SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED INACCURATE HIGH ISSUE BEGAN. THE LFS PRODUCTS WERE REPLACED AND REQUESTED BACK FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335677 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening| R