BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2250155 · Received September 15, 2011

    Report

    Report Number
    2939301-2011-09066
    Event Type
    Injury
    Date Received
    September 15, 2011
    Date of Event
    September 8, 2011
    Report Date
    September 9, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. THE 510(K) # IS K082590.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (11/14/2011)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS/HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(6), 2011WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. IN ADDITION, THE RETAIN TEST STRIPS WERE TESTED AND THEY PASSED TESTING WITH NO FAULTS FOUND. 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 CONTACTED LIFESCAN (LFS) ALLEGING THAT HE WAS EXPERIENCING AN INACCURATE HIGH ISSUE WITH HIS ONE TOUCH PING METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER BEGAN ON (B)(6) 2011, AT 8:22 PM. THE PATIENT OBTAINED A READING OF '310 AND 196 MG/DL' ON THE SUBJECT METER, DONE LESS THAN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20% AND/ OR <=20 MG/DL. HE STATED THAT HE MANAGES HIS DIABETES WITH INSULIN (PUMP THERAPY) AND DUE TO THE ALLEGED ISSUE, AT 8:22 PM HE ADMINISTERED A BOLUS OF 3U OF HUMALOG BASED ON THE '310 MG/DL' RESULT. THE PATIENT CLAIMS WITHIN 1 AND A HALF HOUR LATER, AFTER THE ALLEGED ISSUE BEGAN, HE FELT 'SHAKY'. REPORTEDLY AT 10:22 PM, THE PATIENT STATED HE TESTED AGAIN USING THE SUBJECT METER AND OBTAINED A GLUCOSE RESULT OF '60 MG/DL'. IN RESPONSE TO THE ALLEGED SYMPTOM AND THE SUBJECT METER'S LOW GLUCOSE RESULT, AT 10:22 PM HE SELF TREATED WITH FOOD (ATE A SANDWICH). DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE AGENT NOTED THAT THE PATIENT WAS USING THE CORRECT UNIT OF MEASURE SET IN THE METER, USING CORRECT UNEXPIRED STRIPS AND USING AN APPROVED SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3135077

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening| R