BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 3233472 · Received July 18, 2013

    Report

    Report Number
    3008382007-2013-20155
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 27, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 AND (B)(4) 2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING AND THE COMPLAINT WAS NOT REPRODUCED. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. 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) ALLEGING THAT THE PATIENT¿S ONETOUCH PING METER READ INACCURATELY HIGH COMPARED TO THE PATIENT¿S FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT¿S MOTHER REPORTED THAT THE ALLEGED METER INACCURACY BEGAN ON (B)(6) 2013 AND LASTED APPROXIMATELY 5 DAYS. THE PATIENT¿S MOTHER REPORTED THAT SHE OVER TREATED THE PATIENT IN RESPONSE TO ELEVATED READINGS OBTAINED WITH THE SUBJECT METER. DUE TO OVERTREATMENT, THE PATIENT¿S MOTHER CLAIMED THE PATIENT HAD A LOW BLOOD GLUCOSE EXCURSION ON FOUR SEPARATE OCCASIONS. AT THE TIME OF THE CALL, THE REPORTER STATED THAT ON (B)(6) 2013 AT 10AM THE PATIENT DEVELOPED SYMPTOMS OF ¿MOODY, HUNGRY, IRRITABLE AND A LITTLE THIRSTY¿; SYMPTOMS THE PATIENT ASSOCIATED WITH A HIGH BLOOD GLUCOSE. AT ONSET OF SYMPTOMS THE PATIENT WAS TESTED WITH THE SUBJECT METER AND OBTAINED A READING OF "543 MG/DL". THE REPORTER CLAIMED THE PATIENT WAS ADMINISTERED A CORRECTION BOLUS (AMOUNT NOT KNOWN) IN RESPONSE TO HIGH READING AND SYMPTOMS; HOWEVER, APPROXIMATELY 2 HOURS LATER, SHE DEVELOPED SYMPTOMS OF ¿FEELING SICK TO STOMACH, PALE, CONFUSED AND FELT LIKE PASSING OUT¿. AT ONSET OF SYMPTOMS, THE PATIENT WAS RETESTED AND HER BLOOD GLUCOSE REGISTERED "34 MG/DL". THE PATIENT WAS GIVEN A JUICE BOX TO DRINK AND REPORTEDLY FELT BETTER AFTERWARDS. ON AN UNSPECIFIED DATE/TIME, THE REPORTER ALSO CLAIMED THE PATIENT OBTAINED AN INACCURATE HIGH READING OF "456 MG/DL" WITH THE SUBJECT METER. THE PATIENT¿S MOTHER STATED, THE PATIENT WAS EXPERIENCING HIGH GLUCOSE SYMPTOMS SIMILAR TO ONES SHE DEVELOPED ON (B)(6) 2013. IN RESPONSE TO ELEVATED RESULT, PATIENT WAS ADMINISTERED A CORRECTION BOLUS (AMOUNT NOT KNOWN) AND 2 HOURS LATER DEVELOPED SYMPTOMS OF A LOW. THE REPORTER STATED, THE PATIENT WAS TREATED EITHER WITH JUICE OR GLUCOSE TABLETS. THE REPORTER DID NOT RECALL READINGS OBTAINED ON THE TWO OTHER OCCASIONS THE PATIENT REPORTEDLY DEVELOPED A LOW BLOOD GLUCOSE EXCURSION. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE REPORTER WAS UNABLE TO PERFORM A CONTROL SOLUTION TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT¿S MOTHER CLAIMS THE PATIENT OBTAINED INACCURATE HIGH READINGS ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULTS, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334211 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Life Threatening| R