BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 1894565 · Received November 9, 2010

    Report

    Report Number
    2939301-2010-09768
    Event Type
    Injury
    Date Received
    November 9, 2010
    Report Date
    October 29, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 THE PATIENT'S ONETOUCH PING METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON NOVEMBER 5, 2010 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY BEGAN IN (B)(6) 2010. THE PATIENT CLAIMED THAT ON 10 TO 12 DIFFERENT OCCASIONS (DATES AND TIMES NOT RECALLED) WITHIN 1 WEEK, SHE DEVELOPED SYMPTOMS OF FEELING SHAKY, SWEATY, AND HOT FLASHES APPROXIMATELY 45 MINUTES AFTER ADMINISTERING A CORRECTIVE BOLUS BASED ON A BLOOD GLUCOSE RESULT OBTAINED WITH THE SUBJECT METER. THE PATIENT WAS UNABLE TO RECALL THE ANY OF THE RESULTS OBTAINED WITH THE SUBJECT METER PRIOR TO DEVELOPING THE SYMPTOMS. AT THE ONSET OF SYMPTOMS, THE PATIENT REPORTED THAT SHE WOULD OBTAIN RESULTS ANYWHERE IN THE "90 TO 130 MG/DL" RANGE WITH THE SUBJECT METER, WHICH DID NOT CORRELATE WITH HER SYMPTOMS. WHEN SHE WOULD THEN TEST ON HER BACKUP METER (ONETOUCH ULTRA2) SHE WOULD OBTAIN RESULTS IN THE "40 TO 50 MG/DL" RANGE AND WOULD THEN TREAT HERSELF WITH GLUCOSE TABLETS OR JUICE. THE PATIENT INFORMED THE MSS SHE DISCONTINUED USING THE SUBJECT METER 1 WEEK AFTER THE ALLEGED ISSUE BEGAN AND HAS BEEN TESTING WITH HER BACKUP METER. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE NOTED THAT THE REPORTER DID NOT HAVE CONTROL SOLUTION TO TEST THE REPORTED PRODUCTS. REPLACEMENT ITEMS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED INACCURATE HIGH READINGS 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.

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Life Threatening| R