BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 3298474 · Received August 20, 2013

    Report

    Report Number
    2939301-2013-00643
    Event Type
    Injury
    Date Received
    August 20, 2013
    Report Date
    August 13, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 LAY USER/REPORTER CONTACTED LIFESCAN (LFS) ALLEGING THE METER WAS HAVING AN UNUSUAL ISSUE, IT WAS ¿FREEZING DURING USE,¿ HAD A LINE THROUGH THE DISPLAY AND WAS POWERING OFF DURING USE. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED ON (B)(6) 2013, AT AN UNKNOWN TIME THE ALLEGED ISSUES FIRST OCCURRED. THE PATIENT REPORTED USING INSULIN PUMP THERAPY TO MANGE HER DIABETES. THE PATIENT REPORTED MAKING NO CHANGES TO HER USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED ON AN UNKNOWN DATE AND TIME SHE DEVELOPED SYMPTOMS OF ¿NAUSEA, VOMITING, AND DIZZINESS.¿ THE PATIENT REPORTED SHE WENT TO THE HOSPITAL AND ON (B)(6) 2013 AT AN UNKNOWN TIME READINGS OF ¿571, 213, 124, 66, 180MG/DL¿ WERE OBTAINED AND SHE WAS GIVEN IV FLUIDS WITH HUMALOG INSULIN AS TREATMENT FROM A HEALTHCARE PROFESSIONAL ON (B)(6)2013, AT 2PM. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS UNABLE TO RESOLVE THE ALLEGED ISSUE WITH A WALK THROUGH RETEST. THE PATIENT REPORTED IT WAS NOT THE FIRST TIME THE METER HAD BEEN USED AND THERE WAS NO MISUSE OF THE SUBJECT METER. THE PATIENT WAS EDUCATED ON THE AUTO SHUT OFF FUNCTION, BUT THE ALLEGED ISSUE REMAINED UNRESOLVED. THE PATIENT WAS USING A LITHIUM BATTERY, BUT ALKALINE BATTERIES ARE RECOMMENDED. WHEN THE BATTERIES WERE REPLACE, THE METER WOULD NOT TURN ON. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMS DUE TO THE ALLEGED ISSUES, THE PATIENT REQUIRED TREATMENT FROM AN HCP AND A SEVERELY HIGH BLOOD GLUCOSE READING WAS OBTAINED. THIS INCIDENT DESCRIPTION CONTAINS INFORMATION FROM RELATED (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403910 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3436716

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Hospitalization| L| R