BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2252171 · Received September 16, 2011

    Report

    Report Number
    2939301-2011-09153
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    August 2, 2011
    Report Date
    September 2, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ((B)(6) 2011)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE METER WAS TESTED AND THE ALLEGED COMPLAINT COULD NOT BE CONFIRMED. HOWEVER, A SECONDARY ISSUE WAS OBSERVED WHERE THE LCD WAS FOUND TO BE DEFECTIVE. IN ADDITION, PERFORMANCE TESTING WITH BLOOD WAS PERFORMED ON THE RETAIN TEST STRIPS. THE RETAIN TEST STRIPS FAILED THE PERFORMANCE TESTING WITH BLOOD AND WERE FOUND TO BE BIASED HIGH AT 100 MG/DL. LIFESCAN (LFS) HAS REQUESTED THE RETURN OF THE TEST STRIPS FOR EVALUATION. IF THE TEST STRIPS ARE RETURNED LFS WILL EVALUATE THEM AND INFORM FDA OF THOSE FINDINGS IN A SUPPLEMENTAL REPORT. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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 K082590.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH PING METER WAS INACCURATE HIGH, COMPARING 2 TEST STRIP VIALS OF DIFFERENT LOT NUMBERS WITH HER FEELINGS. ON (B)(6) 2011 THIS MEDICAL SURVEILLANCE SPECIALIST (MSS) CONTACTED THE PATIENT BY PHONE FOR ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT THE ISSUE BEGAN ON (B)(6) 2011 WHEN THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF "280MG/DL" AT 4:08AM WITH THE SUBJECT METER. THE PATIENT MANAGES HER DIABETES WITH AN INSULIN PUMP. BASED ON THE RESULT THE PATIENT TOOK AN INCREASED AMOUNT OF INSULIN. AT 6:13AM THE PATIENT WOKE UP FEELING "SHAKY" AND SHE HAD DEVELOPED A "HEADACHE". THE PATIENT REPORTED THAT SHE ONCE AGAIN TOOK HER BLOOD GLUCOSE AND OBTAINED A RESULT OF 283MG/DL. THE PATIENT TESTED AGAIN AND AT 6:15AM AND OBTAINED A READING OF 225MG/DL. AT 6:18AM THE PATIENT DECIDED TO TEST WITH A DIFFERENT VIAL OF STRIPS (DIFFERENT LOT NUMBER) AND SHE OBTAINED A RESULT OF 67MG/DL. THE PATIENT TESTED AGAIN WITH THE NEW VIAL OF STRIPS AND OBTAINED A RESULT OF 61MG/DL. THE PATIENT ADVISED THAT SHE SELF-TREATED WITH FOOD AND DRINK BASED ON RESULTS OF THE NEW STRIPS AND FELT BETTER AFTERWARDS. THE PATIENT ADVISED THAT AT 6:57AM, SHE TESTED AGAIN WITH THE NEW STRIPS AND OBTAINED A RESULT OF 141MG/DL. AT THE TIME OF TROUBLESHOOTING, THE TECHNICAL SUPPORT REPRESENTATIVE (TSR) NOTED THAT THE PATIENT HAD SET THE UNIT OF MEASUREMENT CORRECTLY AND THAT THE TESTING STRIPS WERE NOT EXPIRED AND HAD BEEN STORED CORRECTLY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY 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. 3010693

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening