BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO2 METER

    MDR report key: 4183450 · Received October 18, 2014

    Report

    Report Number
    2939301-2014-27913
    Event Type
    Injury
    Date Received
    October 18, 2014
    Report Date
    October 13, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K131363
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    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 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) (B)(4) ALLEGING THAT HER ONETOUCH VERIO2 METER WAS DISPLAYING AN ¿ERROR 4¿ MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AS THE PATIENT WAS NOT AVAILABLE TO ANSWER FOLLOW UP QUESTIONS FROM MEDICAL SURVEILLANCE (MS). THE PATIENT DID NOT SPECIFY WHEN THE METER ISSUE OCCURRED. THE PATIENT DETAILED THAT SHE DOES NOT TAKE ANY MEDICATION TO CONTROL HER DIABETES AND CLAIMED THAT SHE CONTINUED HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ERROR MESSAGE. THE PATIENT CLAIMED THAT AT AN UNKNOWN TIME BEFORE THE ERROR MESSAGE OCCURRED, SHE DEVELOPED SYMPTOMS OF ¿BLURRED VISION, LIGHT-HEADEDNESS AND FEELING FAINT¿ WHICH SHE ASSOCIATED WITH HYPOGLYCEMIA. SHE CLAIMED THAT SHE ALSO TESTED WITH A GLUCOMEN METER AND OBTAINED RESULTS OF ¿1.2MMOL/L AND 1.4MMOL/L¿, BUT COULD NOT SPECIFY THE DATE AND TIME OF RESULTS. THE PATIENT REPORTED THAT SHE HAD SUFFERED SEVERAL SIMILAR HYPOGLYCEMIC EVENTS PREVIOUSLY AND THAT THE ERROR 4 MESSAGE HAD ALLEGEDLY CAUSED HER TO SUFFER A FURTHER HYPOGLYCEMIC EVENT. THE PATIENT REPORTED THAT SHE SELF-TREATED WITH FOOD AND/OR DRINK, BUT DID NOT SPECIFY A DATE OR TIME. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE PATIENT HAD USED THE CORRECT TESTING METHOD AND THAT THE TEST STRIPS HAD NOT EXPIRED AND WERE IN GOOD CONDITION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE PATIENT REPORTEDLY SUFFERED A SERIOUS INJURY AFTER THE PRODUCT ISSUE OCCURRED WITH THE SUBJECT METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664107 OT VERIO2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3656697

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Life Threatening| R