BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA TEST STRIPS

    MDR report key: 2843523 · Received November 23, 2012

    Report

    Report Number
    3008382007-2012-06619
    Event Type
    Injury
    Date Received
    November 23, 2012
    Report Date
    November 20, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) K043197. PRODUCT WAS REPLACED AND REQUESTED BACK FOR INVESTIGATION

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER CONTACTED LFS (B)(4) ON (B)(6) 2012 ALLEGING THAT HER DAUGHTER'S TEST STRIPS ARE FAULT AND ARE GIVING ALLEGEDLY HIGH READINGS ON ALL OF HER ULTRA EASY METERS. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION: THE REPORTER MENTIONED THAT HER DAUGHTER HAD DEVELOPED THE SYMPTOMS A MONTH AGO; HOWEVER, DOES NOT RECALL THE EXACT DATE OR DETAILS OF THE EVENT. THE PATIENT HAD OBTAINED A RESULT OF 165 MG/DL AND IMMEDIATELY THE PATIENT HAD DEVELOPED SYMPTOMS OF SHAKY, SWEATY HANDS AND HUNGER. THE MOTHER REALIZED THAT HER DAUGHTER WAS HYPOGLYCEMIC AND TREATED HER WITH SOMETHING TO EAT. THE REPORTER MENTIONED THAT HER DAUGHTER HAD FELT BETTER AFTER THE SELF-TREATMENT AND DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT HER PHYSICIAN FOR ASSISTANCE. THE MOTHER TESTED HERSELF AND ALSO OBTAINED ALLEGEDLY HIGH READINGS. THE REPORTER IS NOT A DIABETIC AND THE MOTHER HAD TESTED SEVERAL TIMES ON ALL OF THE PATIENT'S METERS ((B)(4)) AND THE TEST STRIPS WERE DISPLAYING HIGH RESULTS ON ALL OF THEM . THE PATIENT'S PRIMARY METER IS (B)(4) AND THIS WAS THE METER SHE HAD USED PRIOR TO DEVELOPING SYMPTOMS. REPORTER THEN OPENED A DIFFERENT VIAL OF TEST STRIPS AND THE READINGS ON ALL OF THE METERS WERE "NORMAL." PATIENT TESTS 5X A DAY AND PER MOTHER IS ON AN INTENSE DOSAGE OF INSULIN. OTHER THAN DIABETES, THE PATIENT DOES NOT HAVE ANY OTHER HEALTH CONDITIONS. THE TEST STRIPS WERE REPLACED AND REQUESTED BACK FOR INVESTIGATION. THE COMPLAINT IS BEING REPORTED SINCE THE REPORTER MENTIONED THAT DUE TO THE ALLEGEDLY HIGH READINGS, HER DAUGHTER HAD DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND REPORTER TREATED HER WITH FOOD. PATIENT HAD FELT BETTER AFTER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA TEST STRIPS GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3274431

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Life Threatening| R