BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2932614 · Received January 29, 2013

    Report

    Report Number
    3008382007-2013-01702
    Event Type
    Injury
    Date Received
    January 29, 2013
    Report Date
    January 4, 2013
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER FAILED TESTING. THE METER'S SPC CON 204 WAS FOUND CONTAMINATED. 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) 2013, THE LAY USER/PATIENT'S MOTHER CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HER SON'S ONETOUCH PING METER DOES NOT TURN ON. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE REPORTER ALLEGED THAT POWER ISSUE BEGAN A WEEK PRIOR TO CONTACTING LFS. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (VIA INSULIN PUMP); HOWEVER, THE PATIENT REPORTEDLY DID NOT TAKE ANY ACTION IN RESPONSE TO THE ALLEGED POWER ISSUE. ACCORDING TO THE CSR'S DOCUMENTATION, AS A RESULT OF THE ALLEGED POWER ISSUE, THE PATIENT REPORTEDLY DEVELOPED HYPERGLYCEMIC SYMPTOMS OF BLURRY VISION (IN HIS RIGHT EYE) AND TIREDNESS AT AN UNKNOWN TIME LATER. THE REPORTER DENIED THE PATIENT RECEIVED ANY FORM OF TREATMENT AFTER THE ALLEGED POWER ISSUE OCCURRED. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THE PATIENT WAS NOT USING THE SUBJECT METER FOR THE FIRST TIME, THERE WAS NO MISUSE OF THE LFS PRODUCT, AND THE PATIENT WAS USING THE CORRECT TEST STRIPS (PER OWNER'S BOOKLET RECOMMENDATION). HOWEVER, THE ALLEGED METER POWER ISSUE REMAINS UNRESOLVED. 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
    38949 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3389403

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Life Threatening