BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIDEKICK

    MDR report key: 4792765 · Received April 29, 2015

    Report

    Report Number
    1052693-2015-00665
    Event Type
    Malfunction
    Date Received
    April 29, 2015
    Date of Event
    April 4, 2015
    Report Date
    December 21, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K051147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4) MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION USER'S TEST STRIP HAD POOR STORAGE.INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF "LO" BLOOD RESULTS. EXPECTED BLOOD GLUCOSE RESULTS FASTING RANGE FROM 100 TO 130MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. BACK TO BACK BLOOD TEST PERFORMED DURING CALL SINCE TEST STRIPS DO NOT HAVE PROPER STORAGE. VERIFIED STORAGE OF TEST STRIPS IS WITHIN INSTRUCTED SPECIFICATION SINCE THEY ARE KEPT IN BATHROOM. TEST STRIP LOT MFR'S EXPIRATION DATE IS 10/17/2016 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED NON-FASTING FROM METER MEMORY: "LO", (B)(6) 2015, 07:21PM; 210MG/DL, (B)(6) 2015, 07:21PM; 207MG/DL, (B)(6) 2015, 07:21PM; 261MG/DL, (B)(6) 2015, 07:21PM; 102MG/DL, (B)(6) 2015, 07:21PM. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF "LO" BLOOD RESULTS. EXPECTED BLOOD GLUCOSE RESULTS FASTING RANGE FROM 100 TO 130MG/DL. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REQUIRED AT THIS TIME. BACK TO BACK BLOOD TEST NOT ABLE TO BE PERFORMED DURING CALL SINCE TEST STRIPS DO NOT HAVE PROPER STORAGE. VERIFIED STORAGE OF TEST STRIPS IS NOT WITHIN INSTRUCTED SPECIFICATION SINCE THEY ARE KEPT IN BATHROOM. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/17/2016 AND OPEN VIAL DATE IS (B)(6) 2015. RECALL TEST RESULTS PERFORMED NON-FASTING FROM METER MEMORY: "LO" 04/04/2015 07:21PM. 210MG/DL (B)(6) 2015 07:21PM. 207MG/DL (B)(6) 2015 07:21PM. 261MG/DL (B)(6) 2015 07:21PM. 102MG/DL (B)(6) 2015 07:21PM. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280863 SIDEKICK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. SIDEKICK SR4417

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR