BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2170583 · Received July 21, 2011

    Report

    Report Number
    2939301-2011-06070
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 25, 2011
    Report Date
    June 25, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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. 510(K) # IS K053529.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 ((B)(6) 2011) - DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT 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) 2011, THE LAY USER/PATIENT'S SON CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER. ON (B)(6) 2011 THIS MEDICAL SURVEILLANCE SPECIALIST (MSS) CONTACTED THE PATIENT BY PHONE AND REACHED THE PATIENT'S SON: (B)(6) FOR ADDITIONAL INFORMATION. THE REPORTER STATED THAT THE ALLEGED PRODUCT ISSUE BEGAN ON (B)(6) 2011. THE REPORTER CLAIMED THAT ON (B)(6) 2011 AT 4:36PM, THE PATIENT OBTAINED ALLEGED HIGH BLOOD GLUCOSE READINGS OF "71 MG/DL", WITH THE SUBJECT METER. IT WAS REPORTED THAT THE PATIENT MANAGES HIS DIABETES WITH HUMALOG (4X DAY SLIDING SCALE). THE REPORTER STATED THAT THE PATIENT ADMINISTERED INSULIN (UNKNOWN AMOUNT) AS PART OF HIS REGULAR DIABETES MANAGEMENT AS A RESPONSE TO THE READINGS. THE REPORTER STATED THAT ON (B)(6) 2011 AT 5:00PM, THE PATIENT BECAME "SHAKY, LETHARGIC, AND SLOW TO RESPOND". THE REPORTER CONFIRMED THAT FIRE DEPARTMENT EMS WAS CALLED AND ARRIVED ON JUNE 25, 2011 AT 5:20PM. THE REPORTED STATED THAT A BLOOD GLUCOSE RESULT ON "31MG/DL" WAS OBTAINED ON AN UNKNOWN EMS METER. AS A RESPONSE TO THE READING, EMS ADMINISTERED IV GLUCOSE (UNKNOWN AMOUNT) AND ADVISED THE PATIENT TO EAT A MEAL. THE PATIENT WAS REPORTED AS FEELING BETTER AFTER THE TREATMENT. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE (CCA) CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING AND WAS AN APPROVED SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND RECEIVED HCP TREATMENT FOR SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3132193

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Life Threatening| R