BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT INDUO METER

    MDR report key: 1955478 · Received January 10, 2011

    Report

    Report Number
    2939301-2011-00340
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) # IS K024194. 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), 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HIS ONETOUCH INDUO METER DID NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW UP CALL. THE PATIENT REPORTED THAT THE ALLEGED POWER ISSUE BEGAN ON THE (B)(6), 2011. THE PATIENT INFORMED THE CSR THAT HE TESTS GLUCOSE 6-8X/DAY AND MANAGES HIS DIABETES WITH INSULIN (NOVORAPID AND LANTUS) BASED ON A SLIDING SCALE. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT REPORTED THAT HE TOOK HIS BASE AMOUNT OF NOVORAPID INSULIN (26 UNITS) SINCE HE DID NOT KNOW WHAT HIS BLOOD GLUCOSE WAS. THE PATIENT DENIED DEVELOPING SYMPTOMS; HOWEVER, CLAIMED THAT AS A RESULT OF NOT BEING ABLE TO TEST WITH THE SUBJECT METER HE WENT TO THE EMERGENCY ROOM. THE PATIENT STATED HIS BLOOD GLUCOSE WAS "31 MMOL/L (558 MG/DL)" WHEN TESTED WITH THE ER/HOSPITAL METER AND WAS TREATED WITH 1 UNIT OF INSULIN. THE PATIENT DID NOT RECALL HOW MUCH TIME ELAPSED BETWEEN WHEN THE ALLEGED POWER ISSUE STARTED AND WHEN HE WENT TO THE EMERGENCY ROOM. THE PATIENT WAS ALSO UNABLE TO RECALL THE LAST RESULT OBTAINED WITH THE SUBJECT METER PRIOR TO WHEN THE ISSUE BEGAN. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE PATIENT CONFIRMED THAT HE REPLACED THE SUBJECT METER'S BATTERY AS RECOMMENDED IN THE OWNER'S BOOKLET; HOWEVER, THE ALLEGED ISSUE REMAINED UNRESOLVED. 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 ISSUE AND REPORTEDLY WAS TREATED FOR HYPERGLYCEMIA BY AN HCP AFTER THE ALLEGED POWER ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R