BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2192362 · Received August 4, 2011

    Report

    Report Number
    2939301-2011-06899
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 9, 2011
    Report Date
    July 9, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. 510(K) # IS K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) TO REPORT EXPERIENCING A BATTERY INDICATOR WARNING AND A SUBSEQUENT "ER1" MESSAGE WITH HIS ONE TOUCH ULTRAMINI METER WHEN HE WAS ATTEMPTING TO DO A GLUCOSE TEST. THE COMPLAINT WAS CLASSIFIED BASED ON THE CONVERSATION BETWEEN THE PATIENT AND THE CUSTOMER SERVICE REPRESENTATIVE (CSR) BECAUSE THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/ PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE MSS REVIEWED THE CALL TO OBTAIN AND VERIFY INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER BEGAN ON (B)(6) 2011, AT 9:20 AM. THE PATIENT STATED THAT AFTER SEEING THE BATTERY INDICATOR WARNING, HE REPLACED THE METER'S BATTERY, THEN ENCOUNTERED AN "ER1" PROMPT AND WAS UNABLE TO TEST HIS BLOOD GLUCOSE. HE INFORMED THE CCA THAT HE MANAGES HIS DIABETES WITH INSULIN (NO ADJUSTMENTS), AND DUE TO THE PRODUCT ISSUE, DENIED MAKING ANY CHANGES TO HIS REGULAR TREATMENT. THE PATIENT CLAIMED THAT HE ALLEGEDLY BECAME SHAKY, APPROXIMATELY 4 HOURS LATER, AFTER THE PRODUCT ISSUE BEGAN. HE DENIED RECEIVING MEDICAL TREATMENT DUE HIS SYMPTOM. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE BATTERY WAS NOT DUE FOR REPLACEMENT AND THERE WAS NO INFORMATION OF MISUSE OF METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUES AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3120506

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening