BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA TEST STRIPS

    MDR report key: 2981657 · Received February 27, 2013

    Report

    Report Number
    3008382007-2013-03813
    Event Type
    Injury
    Date Received
    February 27, 2013
    Report Date
    February 12, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K043197
    Adverse Event
    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 IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. DOB: NOT PROVIDED. GENDER: NOT PROVIDED. WEIGHT: NOT PROVIDED. DATE OF EVENT: NOT PROVIDED. TEST STRIP LOT#: NOT PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE HEALTHCARE PROFESSIONAL/REPORTER IN THE (B)(6), A NURSE, CONTACTED LIFESCAN TO REPORT THE PATIENT OBTAINED INACCURATELY LOW BLOOD GLUCOSE READINGS USING ONE TOUCH ULTRA TEST STRIPS IN A BOOTS METER MANUFACTURED BY ANOTHER COMPANY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) CONTACTED THE REPORTER SEVERAL TIMES BUT WAS UNABLE TO REACH HER BY TELEPHONE. THE SR. MEDICAL SURVEILLANCE SPECIALIST CLASSIFIED THE COMPLAINT BASED ON THE INFORMATION INITIALLY PROVIDED TO CUSTOMER SERVICE. THE PATIENT WAS REPORTEDLY ADMITTED TO THE HOSPITAL WITH ELEVATED BLOOD GLUCOSE LEVELS AFTER HE OBTAINED LOW BLOOD GLUCOSE READINGS USING THE ONE TOUCH ULTRA TEST STRIPS IN ANOTHER MANUFACTURER'S METER, A BOOTS METER. THE REPORTER STATED THE PATIENT "MADE INCORRECT TREATMENT DECISIONS" BASED ON THESE INACCURATELY LOW READINGS. IT WOULD HAVE BEEN HELPFUL TO DETERMINE THE INACCURATE READINGS THE PATIENT OBTAINED, WHAT ACTIONS HE TOOK BASED ON THOSE READINGS, IF HE EXPERIENCED ANY SYMPTOMS, HIS ADMITTING BLOOD GLUCOSE LEVEL, HIS ADMITTING DIAGNOSIS AND TREATMENT AND FROM WHOM THE PATIENT OBTAINED THE ONE TOUCH ULTRA TEST STRIPS AND THE BOOTS METER. THE MANUFACTURER'S PACKAGE INSERT FOR THE ONE TOUCH ULTRA TEST STRIPS CLEARLY STATES THESE TEST STRIPS ARE FOR USE ONLY IN THE ONE TOUCH ULTRA FAMILY OF BLOOD GLUCOSE METERS. THE PATIENT'S TESTING TECHNIQUE WAS INCORRECT BY USING THE REPORTED TEST STRIPS IN ANOTHER MANUFACTURER'S METER. HOWEVER, AS THE PATIENT ALLEGEDLY SUFFERED ELEVATED BLOOD GLUCOSE LEVELS AFTER MAKING SELF-TREATMENT DECISIONS BASED UPON INACCURATELY LOW READINGS USING THE ONE TOUCH ULTRA TEST STRIPS IN A BOOTS METER AND WAS HOSPITALIZED, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84208 OT ULTRA TEST STRIPS GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L