BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO PRO METER

    MDR report key: 2477905 · Received March 5, 2012

    Report

    Report Number
    3008382007-2012-00621
    Event Type
    Injury
    Date Received
    March 5, 2012
    Date of Event
    February 12, 2012
    Report Date
    February 13, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. THE 510 (K) # IS K093745.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING INACCURATE HIGH READINGS ON HER METER, WHICH DID NOT MATCH ON HOW SHE WAS FEELING. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS; HOWEVER, THE CUSTOMER CARE ADVOCATE (CCA) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PATIENT. THE COMPLAINT WAS CLASSIFIED BASED ON THE INITIAL CALL. THE PATIENT MENTIONED THAT ON (B)(6) 2012 AROUND 7:15 PM, SHE HAD DEVELOPED SYMPTOMS OF FEELING SHAKY, SWEATY, DIZZY AND LIGHT HEADED. SHE TESTED HER BLOOD GLUCOSE AND OBTAINED A 98 MG/DL ON HER METER. SHE FELT THAT THE RESULT WAS TOO HIGH; THEREFORE, SHE ATE SOME SUGAR. SHE DID NOT TEST HER BLOOD GLUCOSE ON ANOTHER DEVICE. SHE DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ASSISTANCE. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PATIENT'S READINGS PRIOR TO THE EVENT AND THE PATIENT'S DIABETES REGIMEN. PRODUCTS WERE REPLACED AND REQUESTED BACK FOR INVESTIGATION. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT THEY DEVELOPED SYMPTOMS PRIOR TO TESTING, SYMPTOMS WERE SUGGESTIVE OF A SERIOUS INJURY BASED ON LFS DEFINITION AND SYMPTOMS DID NOT REFLECT THEIR BLOOD GLUCOSE METER READING AND HAD TO SELF-TREAT WITH FOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3218097

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Life Threatening| R