BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 3073324 · Received April 23, 2013

    Report

    Report Number
    3008382007-2013-08726
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    March 26, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH PING METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION. THE REPORTER CLAIMED THE SUBJECT DEVICE WAS READING HIGHER THAN THE DOCTOR'S METER. SHE REPORTED THAT DURING A DOCTOR¿S OFFICE VISIT DURING THE FIRST WEEK OF (B)(6) 2013, THE PATIENT TESTED ON THE SUBJECT DEVICE AND OBSERVED A VALUE OF "400 MG/DL". HER DOCTOR PERFORMED A TEST USING THE DOCTOR'S OFFICE METER (ONETOUCH ULTRAMINI) AND REPORTED A VALUE OF "140 MG/DL". THE TIME DIFFERENCE BETWEEN THE 2 TESTS IS NOT KNOWN. IT IS NOT KNOWN HOW THE PATIENT MANAGES HER DIABETES. THE REPORTER CLAIMED THE ALLEGED ISSUE STARTED "AROUND OR BEFORE (B)(6) 2013" BUT DID NOT PROVIDE ANY OF BLOOD GLUCOSE VALUES DURING THAT TIME. IT IS NOT KNOWN WHAT ACTION THE PATIENT REGARDING HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. THE REPORTER DENIED THAT THE PATIENT DEVELOPED ANY SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE. SHE DENIED THAT THE PATIENT RECEIVED ANY FORM OF MEDICAL INTERVENTION OTHER THAN THE GLUCOSE TEST. AT THE TIME OF TROUBLESHOOTING THE REPORTER DID NOT HAVE THE METER OR TESTING SUPPLIES AVAILABLE FOR TROUBLESHOOTING, THEREFORE THE ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT DEVELOP SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR RECEIVE MEDICAL INTERVENTION FOR EITHER OF THESE CONDITIONS. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175418 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3353622

    Patients

    Seq Age Sex Outcome Treatment
    1