BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO2 METER

    MDR report key: 8054258 · Received November 9, 2018

    Report

    Report Number
    3008382007-2018-03108
    Event Type
    Injury
    Date Received
    November 9, 2018
    Date of Event
    November 6, 2018
    Report Date
    November 7, 2018
    Manufacturer
    LIFESCAN EUROPE GMBH
    Product Code
    NBW
    UDI-DI
    00353885008730
    PMA / PMN Number
    K131363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE REPORTER FOR THE PATIENT (PATIENT¿S WIFE) CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO2 METER DISPLAYED INACCURATE HIGH RESULTS COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE REPORTER CONFIRMED THAT THE INACCURACY ISSUE BEGAN ON (B)(6) 2018, AT AROUND 7:30 AM WHEN PATIENT OBTAINED ALLEGED INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿250, 259 AND 306 MG/DL¿ WITH THE SUBJECT METER. METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE THE POSSIBILITY OF INACCURACY. THE PATIENT MANAGES HIS DIABETES WITH HUMULIN (70/30 IN THE MORNING) AND HUMULIN R (AT LUNCH), AND THE REPORTER CONFIRMED THAT THE PATIENT DID NOT MAKE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT IN RESPONSE TO THE ALLEGED ISSUE. THE REPORTER INDICATED THAT, ALMOST 5 HOURS AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT STARTED TO DEVELOP SYMPTOMS OF ¿DOUBLE VISION, TREMENDOUS HEADACHE, SWEATING PROFUSELY AND HAVING TROUBLE PEEING¿. THE REPORTED INFORMED THE CSR THAT, AT AROUND 12:00 PM, THE PATIENT ATE ¿CHEXMIX: LIKE CEREAL OR PRETZEL¿ AND FELT BETTER AFTERWARDS. THE REPORTER STATED THAT, BETWEEN 12:30-13:00 PM, THE PATIENT VISITED EMERGENCY ROOM WHERE HIS BLOOD PRESSURE WAS CHECKED. DURING TROUBLESHOOTING, IT WAS ESTABLISHED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE AND THE STRIPS USED HAD NOT BEEN OPEN LONGER THAN THE DISCARD DATE, HAD NOT EXPIRED, AND HAD BEEN STORED CORRECTLY. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT AFTER THE ALLEGED PRODUCT ISSUE BEGAN. THE SUBJECT METER COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895660 OT VERIO2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE GMBH 4371770 00353885008730

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R