BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2392129 · Received December 29, 2011

    Report

    Report Number
    2939301-2011-12928
    Event Type
    Malfunction
    Date Received
    December 29, 2011
    Report Date
    December 14, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) # 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) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN REPORTING IMPRECISE BLOOD GLUCOSE READINGS WITH THE SUBJECT METER. THE REPORTED ISSUE FIRST OCCURRED ON (B)(6) 2011 AT 2:20PM WHEN THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE READINGS OF "220, 591, 222, 480, 222, 253 MG/DL" WITHIN A 20 MINUTE TIME PERIOD. THE PATIENT SELF TREATED WITH 0.5 UNITS OF NOVOLOG; HOWEVER, DENIED HAVING ANY SYMPTOMS AT THE TIME AND DID NOT REPORT ANY OTHER FORMS OF MEDICAL INTERVENTION. THE REPORTED RESULTS DID NOT MEET LIFESCAN'S PRECISION CRITERIA. THE CUSTOMER SERVICE REPRESENTATIVE TROUBLESHOT THE ALLEGED INACCURACY ISSUE WITH THE PATIENT AND NOTED THAT THE CORRECT TESTING STEPS AND APPROVE SAMPLE SITES WERE USED FOR TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE PATIENT DID NOT SUFFER FROM ANY SERIOUS INJURIES AND DID NOT RECEIVE ANY FORM OF MEDICAL INTERVENTION THAT WOULD INDICATE A SERIOUS INJURY. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED INACCURACY ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3209447

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR