BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 1862370 · Received October 8, 2010

    Report

    Report Number
    2939301-2010-08944
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 26, 2010
    Report Date
    September 26, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510K # IS K082590. 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) 2010, THE LAY USER/PATIENT'S MOTHER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH PING METER WAS READING INACCURATELY HIGH. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE REPORTER ON (B)(6) 2010 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT'S MOTHER REPORTED THAT ON (B)(6) 2010 AT 10:28AM THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF "419 MG/DL" WITH THE SUBJECT METER. THE PATIENT IS A TYPE 1 DIABETIC AND ON AN INSULIN PUMP. IN RESPONSE TO THE READING, THE REPORTER STATED THAT THE PATIENT TOOK A CORRECTIVE BOLUS (AMOUNT NOT RECALLED). APPROXIMATELY 1 HOUR LATER, THE PATIENT'S MOTHER CLAIMED THAT THE PATIENT APPEARED VERY PALE, COULD NOT STAND, WAS SHAKING, AND COMPLAINED THAT HE "COULD NOT SEE." AT THE ONSET OF THE SYMPTOMS, THE REPORTER TESTED THE PATIENT WITH THE SUBJECT METER AND OBTAINED A RESULT OF "155 MG/DL" WHICH SHE DID NOT FEEL WAS ACCURATE. DESPITE THE ALLEGED INACCURATE RESULT, THE PATIENT'S MOTHER IMMEDIATELY TREATED THE PATIENT WITH PEACH SYRUP AND DONUTS. THE REPORTER CONFIRMED THAT THE PATIENT RESPONDED TO THE TREATMENT AND FELT BETTER AFTERWARDS. THE REPORTER INFORMED THE MSS THAT SHE DID TAKE THE PATIENT TO THE EMERGENCY ROOM. AT THE TIME HE ARRIVED TO THE ER, THE PATIENT'S MOTHER REPORTED THAT THE PATIENT'S BLOOD GLUCOSE WAS "235 MG/DL" WHEN TESTED WITH A HOSPITAL METER. THE REPORTER DENIED THAT THE PATIENT RECEIVED ANY ADDITIONAL TREATMENT WHILE IN THE ER. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE NOTED THAT THE REPORTER DID NOT HAVE CONTROL SOLUTION TO TEST THE REPORTED PRODUCTS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT'S MOTHER CLAIMS THE PATIENT 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. 2998225

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R