BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 4112419 · Received September 24, 2014

    Report

    Report Number
    2939301-2014-25165
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Report Date
    September 20, 2014
    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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 - 3/26/2015 DEVICE EVALUATION.THE LAY USER/PATIENTS METER HAS BEEN RETURNED ON 10/13/2014 AND FURTHER EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 12/30/2014 WITH THE FOLLOWING FINDINGS:ERROR MESSAGE 5 OBSERVED IN THE ERROR LOG, BUT THE ERRORS WERE NOT REPRODUCED DURING THE INVESTIGATION. IN ADDITION A SECONDARY ISSUE WAS NOTED; THE METER WAS FOUND TO HAVE A LOW/DEAD BATTERY. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THEIR ONETOUCH PING METER DISPLAYED AN ¿ERROR 5¿ MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER ISSUE BEGAN "A FEW WEEKS AGO" WHEN THEY ATTEMPTED TO MEASURE THEIR BLOOD GLUCOSE. THE PATIENT MANAGES THEIR DIABETES USING HUMALOG. THE PATIENT REPORTED INCREASING THEIR FOOD/DRINK CONSUMPTION IN RESPONSE TO THE ALLEGED METER ISSUE. THE PATIENT DENIED EXPERIENCING ANY SYMPTOMS IN RESPONSE TO THE ALLEGED METER ISSUE. THE PATIENT REPORTED OBTAINING RESULTS OF ¿201, 113, 232 AND 551MG/DL¿ USING ANOTHER DEVICE (BRAND UNKNOWN) AT APPROXIMATELY 8 PM ON (B)(6) 2014. THE PATIENT REPORTED TREATING THEMSELVES WITH INCREASED FOOD/DRINK IN RESPONSE TO THE ALLEGED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT IT WAS NOT THE FIRST USE OF THE PRODUCT AND THE TESTING PROCEDURE WAS CORRECT. THE CSR ALSO NOTED THAT THE PATIENT DID NOT HAVE ANY TEST STRIPS, AND THE ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS WERE 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
    593333 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1