BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 3250436 · Received July 26, 2013

    Report

    Report Number
    3008382007-2013-21220
    Event Type
    Injury
    Date Received
    July 26, 2013
    Report Date
    July 1, 2013
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ((B)(4) 2013)-PRODUCT EVALUATION: THE ANALYSIS OF THE SUBJECT METER WAS COMPLETED ON (B)(4) 2013 BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE REPORTED DISPLAY ISSUE WAS CONFIRMED IN THE LABORATORY. THE ANALYSIS OF THE SUBJECT METER FOUND THAT THE LCD SCREEN WAS BROKEN.. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT PRODUCT(S) HAS BEEN RETURNED TO LIFESCAN FOR EVALUATION. THE EVALUATION OF THE PRODUCTS HAVE NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRASMART METER¿S DISPLAY WAS CRACKED. ON (B)(6) 2013, THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT TO OBTAIN AND VERIFY INFORMATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON EITHER (B)(6) 2013 BETWEEN 6:30-7PM. SHE WAS UNABLE TO USE THE SUBJECT DEVICE DUE TO THE CRACKED DISPLAY. THE PATIENT ADVISED THE MSS THAT SHE MANAGES HER DIABETES WITH HUMALOG INSULIN BASED ON A SLIDING SCALE 3X PER DAY, LANTUS INSULIN, 55 UNITS AT BEDTIME AND BYETTA, 5MG 2X PER DAY. IN RESPONSE TO NOT BEING ABLE TO TEST, SHE REPORTEDLY CHANGED HER SLIDING SCALE DOSE OF HUMALOG TO A BASE AMOUNT. SHE CLAIMED THAT A FEW HOURS LATER, SHE DEVELOPED SYMPTOMS OF ¿SHAKING, SWEATING AND DIZZINESS,¿ WHICH SHE ASSOCIATED WITH LOW BLOOD GLUCOSE SYMPTOMS. SHE REPORTED THAT SHE SELF TREATED APPROXIMATELY 30 MINUTES LATER WITH GLUCOSE LIQUID/SOLUTION AFTER PURCHASING IT FROM THE PHARMACY. HER SYMPTOMS ABATED WITHIN 10 MINUTES OF DRINKING THE SOLUTION. NO OTHER DEVICE WAS USED FOR TESTING AT THE TIME. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME. THERE WAS NO REPORT OF TRAUMA/MISUSE OF THE DEVICE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT AND SUBJECT PRODUCT WAS REQUESTED BACK FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351489 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3434230

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Life Threatening| R