BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 6039079 · Received October 19, 2016

    Report

    Report Number
    3008382007-2016-53745
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Report Date
    September 27, 2016
    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
    CA, 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.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2016 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THEIR ONETOUCH PING METER WAS NOT POWERING ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT STATED THAT THE ALLEGED METER ISSUE BEGAN ON (B)(6) 2016 AT 4PM. THE PATIENT STATED THAT THEY MANAGE THEIR DIABETES USING AN INSULIN PUMP AND DID NOT SPECIFY MAKING ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT REPORTEDLY EXPERIENCED SYMPTOMS OF "NAUSEOUS"APPROXIMATELY 7 HOURS AFTER THE ALLEGED ISSUE BEGAN AND REPORTEDLY DECREASED HER DOSE OF HUMALOG INSULIN AT 11:30PM THAT NIGHT IN RESPONSE TO THE REPORTED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CSR CONFIRMED THAT IT WAS NOT THE PATIENT'S FIRST USE OF THE PRODUCT, AND THERE HAD BEEN NO MISUSE. THE CSR CONFIRMED THAT THE CORRECT TEST STRIPS WERE BEING USED AND THE METER DID TURN-ON WHEN THE POWER BUTTON WAS PRESSED. THE CSR WAS UNABLE TO RESOLVE THE ISSUE WITH TROUBLESHOOTING. RETURN OF THE SUBJECT DEVICE WAS REQUESTED FOR INVESTIGATION AND REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT. 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 AS A MALFUNCTION BECAUSE THE ALLEGED METER/PRODUCT ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693978 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4015690

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR