BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 4133912 · Received October 2, 2014

    Report

    Report Number
    2939301-2014-26029
    Event Type
    Injury
    Date Received
    October 2, 2014
    Report Date
    September 22, 2014
    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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 ¿ (11/11/2014). THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON 10/28/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 10/28/2014 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE TEST STRIPS WERE FOUND TO HAVE RESULTS BELOW RANGE WHEN TESTED WITH CONTROL SOLUTION. 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

    FOLLOW-UP # 1 ¿ (10/17/2014), THE PATIENT¿S METER HAS BEEN RETURNED ON 10/6/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 10/8/2014 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. 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¿S MOTHER (REPORTER) CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH PING METER READ INACCURATELY ERRATIC. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THREE WEEKS PRIOR TO CONTACTING LFS (DATE/TIME NOT SPECIFIED) THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE READINGS OF ¿350, 120, AND 50MG/DL¿ WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. THE PATIENT MANAGES HIS DIABETES WITH INSULIN PUMP THERAPY. ACCORDING TO THE CSR¿S DOCUMENTATION IN RESPONSE TO THE REPORTED METER ISSUE THE PATIENT REPORTEDLY SKIPPED HIS MEDICATION AND SUBSEQUENTLY 30 MINUTES AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF HUNGER AND BLURRY VISION; THE REPORTER ALLEGEDLY ADMINISTERED FOOD AND/OR DRINK AS TREATMENT AN UNSPECIFIED TIME LATER. THE REPORTER DENIED THE PATIENT TESTED WITH ANOTHER DEVICE. DURING TROUBLESHOOTING, THE CSR CONFIRMED THE PATIENT WAS USING THE PROPER TESTING TECHNIQUE, THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING, AND THE BLOOD GLUCOSE RESULTS WERE FROM THE APPROVED (PER OWNER¿S BOOKLET) SAMPLE SITE. THE CSR ALSO NOTED THE REPORTER PERFORMED A QUALITY CONTROL SOLUTION TEST WHICH PASSED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY SUFFERED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615554 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3560435

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Life Threatening| R