BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2960214 · Received February 14, 2013

    Report

    Report Number
    3008382007-2013-03009
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 8, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ((B)(4) 2013)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS (PA) ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER PASSED TESTING WITH NO FAULTS FOUND. THE METER WAS FOUND TO FUNCTION PROPERLY. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. 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) 2013, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH PING METER READ INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2013 AT 647AM. THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF "432 MG/DL" WITH THE SUBJECT METER. THE PATIENT MANAGES HIS DIABETES WITH NOVOLOG INSULIN THROUGH PUMP THERAPY. BASED ON THE ALLEGED RESULT, THE PATIENT ADMINISTERED HIS USUAL DOSE OF INSULIN (1 UNIT PER EVERY 100 MG/DL). THAT SAME MORNING AT SCHOOL, THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF "52 MG/DL" (AT 11AM) AND "57 MG/DL" (AT 12PM) WITH THE SCHOOL NURSE'S METER. THE PATIENT WAS GIVEN A JUICE BOX AND LUNCH AS TREATMENT. AROUND 1230PM, THE PATIENT'S MOTHER WAS CONTACTED TO PICK HIM UP FROM SCHOOL. THE REPORTER CLAIMS THE PATIENT HAD SYMPTOMS OF HEADACHE, DIZZY, LETHARGY, PALE AND NAUSEATED WHICH THEY ASSOCIATED WITH LOW BLOOD GLUCOSE. LATER THAT AFTERNOON, THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE RESULTS OF "372, 327, 304, 497, HI MG/DL (OVER 600 MG/DL), 555 AND 440 MG/DL" WITH THE SUBJECT METER AND ADMINISTERED INSULIN BASED ON EACH REPORTED RESULT. THE REPORTER CONFIRMED, THE PATIENT HAD RELATED HIGH BLOOD GLUCOSE SYMPTOMS OF FRUSTRATED, HYPERACTIVE, AGITATED, SWEATY, THIRSTY AND FREQUENT URINATION. ABOUT 945PM, THE PATIENT WAS REPORTEDLY TAKEN TO THE EMERGENCY ROOM (ER) AND OBTAINED A BLOOD GLUCOSE RESULT OF "385 MG/DL" WITH THE ER METER. THE PATIENT WAS ADMINISTERED 10 UNITS INSULIN (TYPE NOT SPECIFIED). LATER THAT EVENING, THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF "419 MG/DL" WITH THE SUBJECT METER AND "230 MG/DL" ON THE ER METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE PATIENT WAS SENT HOME THAT SAME EVENING. AROUND 11PM WHILE AT HOME, THE PATIENT HAD REPORTEDLYOBTAINED A BLOOD GLUCOSE RESULT OF "145 MG/DL" WITH THE SUBJECT METER. AT THAT TIME, THE REPORTER CLAIMS THE PATIENT FELT SYMPTOMS OF SHAKY AND PALE. THE PATIENT ATE CEREAL AS TREATMENT. ABOUT 20 MINUTES LATER, THE PATIENT REPORTEDLY FELT BETTER AND OBTAINED A BLOOD GLUCOSE RESULT OF "80 MG/DL." THE REPORTER CONFIRMED PRIOR TO THE START OF THE ALLEGED ISSUE THE PATIENT'S BLOOD GLUCOSE RESULTS WERE NORMAL AND ANY SYMPTOMS HE EXPERIENCED CORRELATED WITH HIS BLOOD GLUCOSE RESULTS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. 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 ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64869 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3371323

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| L| R