BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING ENHANCED METER

    MDR report key: 2981989 · Received February 28, 2013

    Report

    Report Number
    3008382007-2013-03935
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    February 19, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (06/17/2013)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 06/06/2013 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. THE COMPLAINT 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

    FOLLOW-UP # 2 ¿ (07/19/2013) THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 AND (B)(4) 2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS: THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE 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 PATIENT'S MOM/REPORTER CONTACTED LIFESCAN (LFS) CANADA ALLEGING THAT THE ONETOUCH PING METER HAS BEEN GIVING ELEVATED BLOOD GLUCOSE WHILE THE PATIENT HAD SIGNS AND SYMPTOMS OF "KETONES AND VOMITING." THE PATIENT DEVELOPED THE SIGNS AND SYMPTOMS ON (B)(6) 2012. AT AROUND 12:00 PM, THE PATIENT WAS VOMITING AND ADMINISTERED SELF TREATMENT WITH INSULIN PUMP THERAPY. HER KETONES AND BLOOD GLUCOSE EVENTUALLY WENT TO NORMAL LEVEL. HOWEVER, AT AROUND 4 PM, THE PATIENT'S BLOOD GLUCOSE BEGAN TO RISE AGAIN. THE PATIENT WENT TO THE ER WHERE SHE WAS MONITORED FOR 1-2 MONITOR. REPORTEDLY, HER BLOOD GLUCOSE WAS COMPARED BETWEEN THE HOSPITAL METER, A BACKUP METER, AND THE SUBJECT METER. THE PATIENT CLAIMED THE SUBJECT METER GAVE HIGHER READINGS THAT WERE 2 TO 5 MMOL/L HIGHER. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "20.8 MMOL/L" (374 MG/DL) WITH A LIFESCAN METER AND "15.8 MMOL/L" (284 MG/DL) ON THE HOSPITAL METER AND BACKUP 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 <= 1.7 MMOL/L. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED INACCURATE HIGH OBTAINED ON THE SUBJECT METER. HOWEVER, THERE IS NO EVIDENCE THE SUBJECT METER CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S SYMPTOMS AND TREATMENT CORRELATED WITH THE REPORTED ELEVATED BLOOD GLUCOSE READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88616 OT PING ENHANCED METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR