BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOSP SS FLEXX METER LASER

    MDR report key: 3163210 · Received June 11, 2013

    Report

    Report Number
    3008382007-2013-16677
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 23, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K081019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 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) 2013 THE HEALTHCARE PROFESSIONAL (HCP)/REPORTER CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT WAS UNABLE TO TEST HIS OR HER BLOOD GLUCOSE DUE TO THE METER HAVING A DATA PORT CONNECTION ISSUE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO CONTACT THE PATIENT FOR A FOLLOW UP CALL. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER STATED THE ALLEGED ISSUE FIRST OCCURRED ON (B)(6) 2013 AT 3:55 PM. IT IS UNKNOWN WHAT MEDICATIONS THE PATIENT TAKES TO MANAGE HIS OR HER DIABETES. THE REPORTER STATED NO CHANGES WERE MADE TO THE PATIENT¿S USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS. THE REPORTER STATED THE PATIENT DID NOT DEVELOP ANY SYMPTOMS DUE TO THE ALLEGED ISSUE. THE REPORTER STATED ON (B)(6) 2013 THE PATIENT WAS HOSPITALIZED DUE TO AN UNKNOWN ISSUE. THE REPORTER STATED ON 05/23/2013 AT 3:59 PM THE PATIENT WAS GIVEN INSULIN, AND A READING OF GREATER THAN ¿70 MG/DL¿ WAS OBTAINED. AT THE TIME OF TROUBLE SHOOTING, THE CCA DOCUMENTED THERE WAS NO MISUSE OF THE SUBJECT METER AND IT WAS NOT THE FIRST TIME THE METER HAD BEEN USED. REPLACEMENT PRODUCTS WERE SENT TO THE HOSPITAL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMS DUE TO THE ALLEGED ISSUE, THE PATIENT REQUIRED TREATMENT FROM A HEALTHCARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264022 HOSP SS FLEXX METER LASER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3404913009

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R