BEUDAMED
    FDA Adverse Event Injury Summary report: N

    USERS MANUALS

    MDR report key: 2850111 · Received November 29, 2012

    Report

    Report Number
    3008382007-2012-06886
    Event Type
    Injury
    Date Received
    November 29, 2012
    Report Date
    November 1, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    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) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) TO REPORT THAT THE USER GUIDE THAT CAME IN HER ONETOUCH ULTRAMINI KIT WAS IN (B)(4). THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) DURING A FOLLOW-UP CALL WITH THE PATIENT. THE PATIENT INFORMED THE MSS THAT SHE RECEIVED THE NEW METER KIT THREE DAYS PRIOR TO CONTACTING LFS AND IMMEDIATELY NOTICED THE LITERATURE WAS IN SPANISH. THE PATIENT STATED THE METER WAS NEW TO HER AND AS A RESULT OF THE USER'S GUIDE BEING IN THE INCORRECT LANGUAGE SHE DID NOT KNOWN HOW TO USE THE METER TO TEST HER BLOOD GLUCOSE. THE PATIENT STATED, SHE DID NOT HAVE ANY OTHER METER AVAILABLE TO TEST HER BLOOD GLUCOSE AT THAT TIME. THE PATIENT INFORMED THE MSS THAT SHE MANAGES HER DIABETES WITH HUMULIN N AND HUMALOG BASED ON A SLIDING SCALE. BECAUSE, SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE WITH THE LFS METER, THE PATIENT STATED, SHE ESTIMATED HOW MUCH INSULIN TO GIVE HERSELF. APPROXIMATELY A COUPLE OF DAYS AFTER RECEIVING THE METER KIT, THE PATIENT STATED, SHE BECAME SWEATY, A SYMPTOM SHE ASSOCIATED WITH A LOW BLOOD GLUCOSE. IN RESPONSE TO THE SYMPTOM, THE PATIENT REPORTED THAT SHE ATE SOMETHING AND FELT BETTER AFTERWARDS. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER HAVING RECEIVED LITERATURE IN THE INCORRECT LANGUAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 USERS MANUALS GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R