BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 3970159 · Received July 31, 2014

    Report

    Report Number
    2939301-2014-19267
    Event Type
    Injury
    Date Received
    July 31, 2014
    Report Date
    July 25, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K021819
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    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. D4 TEST STRIP LOT #: INFORMATION WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (12/15/2014). THE PATIENT¿S METER HAS BEEN RETURNED ON 12/2/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 12/5/2014 WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(6) ALLEGING SHE OBTAINED AN ERROR 1 MESSAGE WITH HER ONETOUCH ULTRASMART METER. MEDICAL SURVEILLANCE SENT FOLLOW-UP QUESTIONS; HOWEVER CUSTOMER SERVICE (CS) WAS UNSUCCESSFUL IN REACHING THE PATIENT BY PHONE. THE COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CS REPRESENTATIVE DURING THE PATIENT¿S INITIAL CALL. THE PATIENT ALLEGED THAT THE ISSUE OCCURRED JUST BEFORE DINNER (AT APPROXIMATELY 10PM) ON (B)(6) 2014. THE PATIENT MANAGES HER DIABETES WITH INSULIN (SELF-ADJUSTER). ACCORDING TO THE CSR¿S DOCUMENTATION AFTER THE ALLEGED ISSUE OCCURRED THE PATIENT WENT AHEAD AND REPORTEDLY ADMINISTERED 4 UNITS OF RAPID INSULIN AND SUBSEQUENTLY TWO HOURS LATER, SHE DEVELOPED UNSPECIFIED SYMPTOM(S) OF HYPOGLYCEMIA. PER CSR¿S DOCUMENTATION, THE PATIENT DID NOT RECEIVE ANY FORM OF MEDICAL TREATMENT AFTER THE REPORTED PRODUCT ISSUE OCCURRED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING: THE PATIENT¿S TESTING FREQUENCY AND DIABETES MANAGEMENT; WAS THE PATIENT¿S DOSE OF 4 UNITS (AT THAT TIME OF THE EVENING) A TYPICAL DOSAGE OF HER REGIMEN AND DOES THE PATIENT ADMINISTER THE SAME DOSE DESPITE WHAT HER BLOOD GLUCOSE READING IS; SINCE THE PATIENT STILL KNOWINGLY ADMINISTERED HER INSULIN DESPITE NOT BEING ABLE TO OBTAIN A READING, DID THE PATIENT TRY TO CONSUME MORE FOOD; DID THE PATIENT TEST HER BLOOD GLUCOSE WITH ANOTHER DEVICE AFTER THE ALLEGED ISSUE OCCURRED; WHAT SPECIFIC SYMPTOM(S) DID THE PATIENT DEVELOP; WHAT DID THE PATIENT DO TO TREAT HER SYMPTOM(S); AND WHEN DID THE PATIENT¿S SYMPTOM(S) ABATE. DURING TROUBLESHOOTING, THE CSR NOTED THE PATIENT WAS NOT USING THE SUBJECT METER FOR THE FIRST TIME. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY SUFFERED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448353 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening