BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 6295639 · Received February 2, 2017

    Report

    Report Number
    3008382007-2017-05501
    Event Type
    Injury
    Date Received
    February 2, 2017
    Report Date
    January 26, 2017
    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
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENTS TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS FAILED TESTING. THE REPORTED ISSUE WAS CONFIRMED. 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

    THE LAY USER/PATIENT¿S TEST STRIPS HAVE BEEN FURTHER EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE ADDITIONAL TESTS PERFORMED ON THE TEST STRIP VIAL AND THE DESICCANT WERE TO CHECK THE STRUCTURAL INTEGRITY AND FOR A POSSIBLE MOISTURE ISSUE. THE STRUCTURAL INTEGRITY OF THE TEST STRIP VIAL WAS FOUND TO BE INTACT DURING A GROSS LEAK TEST. THE DESICCANT WITHIN THE SUBJECT VIAL WAS FOUND TO CONTAIN MORE MOISTURE THAN EXPECTED FROM NORMAL USE (AS PER PRODUCT LABELLING). A DEVICE HISTORY RECORD REVIEW WAS ALSO PERFORMED ON THE SUBJECT TEST STRIP LOT. THE REVIEW DID NOT IDENTIFY ANYTHING THAT COULD ADVERSELY IMPACT PRODUCT PERFORMANCE OR FUNCTION. 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) 2017, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH PING METER READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT STATED THAT THE ALLEGED INACCURACY OCCURRED AT 6:04PM ON (B)(6) 2017. AT THIS TIME THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF ¿180, 196 AND 205MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MANAGES THEIR DIABETES WITH INSULIN PUMP THERAPY AND STATED THAT THEY INCREASED THEIR DOSAGE OF NOVALOG INSULIN BY 4.5 UNITS AT 6:04PM, 1.5 UNITS AT 7PM AND 1 UNIT AT 7:05PM THE SAME DAY. THE PATIENT STATED THAT ONE HOUR AND TWENTY MINUTES AFTER THE ALLEGED PRODUCT ISSUE OCCURRED THEY DEVELOPED SYMPTOMS OF ¿FELT LIKE PASSING OUT, SHAKY, DIZZY AND LIGHTHEADED¿; SYMPTOMS WHICH THE PATIENT ASSOCIATED WITH HYPOGLYCEMIA. THE PATIENT SELF-TREATED THESE SYMPTOMS BY CONSUMING ADDITIONAL FOOD AND/OR DRINK. AT THE TIME OF TROUBLESHOOTING THE CCA NOTED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER AND THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO WALK THROUGH A CONTROL SOLUTION TEST. THE PATIENT¿S PRODUCTS WERE REPLACED AND REQUESTED FOR EVALUATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS TO HAVE OBTAINED INACCURATELY HIGH READINGS ON THE SUBJECT METER WHICH LED TO THEM DEVELOPING SIGNS/SYMPTOMS WHICH MEET LFS¿S CRITERIA FOR A SERIOUS INJURY REPORTABLE ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80590 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3946543

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening