BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2862474 · Received December 10, 2012

    Report

    Report Number
    3008382007-2012-07497
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 11, 2012
    Report Date
    November 12, 2012
    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
    MI, 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) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH PING METER WAS DISPLAYING THE BATTERY INDICATOR AND DOES NOT TURN ON. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE POWER ISSUE BEGAN ON (B)(6) 2012 (TIME NOT KNOWN). THE PATIENT REPORTEDLY MANAGES HIS DIABETES WITH INSULIN VIA INSULIN PUMP; HOWEVER, IN RESPONSE TO THE ALLEGED POWER ISSUES, THE PATIENT REPORTEDLY CONSUMED LESS FOOD ON (B)(6) 2012 (TIME NOT SPECIFIED). AS A RESULT OF THE ALLEGED ISSUES, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF NAUSEA, THIRST, AND FREQUENT URINATION TWO DAYS LATER. THE PATIENT DENIED TESTING HIS BLOOD GLUCOSE WITH ANOTHER DEVICE AFTER THE ALLEGED ISSUES OCCURRED. ACCORDING TO THE CSR'S DOCUMENTATION ON (B)(6) 2012 (AT 10:30AM), THE PATIENT REPORTEDLY CONTACTED HER PHYSICIAN BY PHONE AND SHE WAS ADVISED TO ADMINISTER 15 UNITS OF NOVOLOG INSULIN PER DAY. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE PATIENT WAS NOT USING THE SUBJECT METER FOR THE FIRST TIME, THERE WAS NO MISUSE OF THE LFS PRODUCT, AND THE SUBJECT METER'S BATTERIES DID NOT NEED TO BE REPLACED PER OWNER'S BOOKLET RECOMMENDATION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUES BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3308975

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Life Threatening| R