BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 4814793 · Received June 3, 2015

    Report

    Report Number
    2939301-2015-22565
    Event Type
    Injury
    Date Received
    June 3, 2015
    Report Date
    May 16, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1.THE LAY USER/PATIENTS TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE REPORTED ISSUE COULD NOT BE CONFIRMED HOWEVER A SECONDARY ISSUE WAS NOTED; THE TEST STRIPS WERE FOUND TO HAVE RESULTS BELOW RANGE WHEN TESTED WITH CONTROL SOLUTION. THE RETAIN TEST STRIPS PASSED ALL TESTING. 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) 2015, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH PING METER WAS READING INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) DURING A FOLLOW-UP CALL WITH THE PATIENT ON (B)(6) 2015. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY ISSUE BEGAN AT AN UNSPECIFIED TIME ON (B)(6) 2015. THE PATIENT REPORTED OBTAINING ALLEGED INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿162, 192, 184, 247 AND 259 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MANAGES HER DIABETES WITH INSULIN PUMP THERAPY. DURING THE FOLLOW-UP CALL, THE PATIENT REPORTED ADMINISTERING INCREASED DOSES OF INSULIN IN RESPONSE TO THE ELEVATED RESULTS. THE PATIENT CLAIMED THAT AN UNKNOWN TIME AFTER THE ALLEGED ISSUE STARTED, SHE EXPERIENCED ¿SEVERAL LOWS AND BECAME SHAKY AND SWEATY¿. THE PATIENT REPORTED TREATING HERSELF WITH GLUCOSE TABLETS IN RESPONSE TO HER SYMPTOMS. DURING TROUBLESHOOTING, THE CUSTOMER SERVICE REPRESENTATIVE (CSR) CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER TAKING AN INCREASED DOSE OF INSULIN BASED ON ALLEGED INACCURATE HIGH RESULTS OBTAINED WITH THE SUBJECT METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360575 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3678698

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening| R