BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA COMBO

    MDR report key: 3001171 · Received March 13, 2013

    Report

    Report Number
    2183996-2013-00383
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 27, 2013
    Report Date
    August 4, 2025
    Manufacturer
    ROCHE DIAGNOSTICS GMBH
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    IU RECEIVED ONE METER SN (B)(4) WITH THREE BATTERIES. IU PERFORMED PRODUCT ASSESSMENT OF THE RETURNED METER AND OBSERVED THAT THE METER WAS PREVIOUSLY SYNCHRONIZED TO PUMP SN (B)(4). IU WAS ABLE TO SYNCHRONIZE THE METER WITH RETENTION PUMP SN (B)(4). IU OBSERVED THAT THE METER PAIRED WITH PUMP CORRECTLY. IU WAS ABLE TO CONNECT METER TO PUMP USING BLUETOOTH COMMUNICATION. PUMP AND METER COMMUNICATION IS ACCEPTABLE. IU OBSERVED THAT THE METER POWERED AND FUNCTIONED AS EXPECTED WITH ON/OFF BUTTON OR STRIP INSERTION WITH ACCEPTABLE RETENTION BATTERIES. IU TESTED THE RETURNED METER USING RETENTION STRIP LOT 491094 EXP. 12/2013, RETENTION UNIVERSAL ROM KEY CONFIGURATION 112, RETENTION CONTROLS LOT 20100110 EXP. 01/2014 AND THE RETURNED BATTERIES. CONTROL RANGES: LOW-LEVEL: 1.7 - 3.3 MMOL/L, MID-LEVEL: 5.4 - 7.3 MMOL/L RESULTS: LOW-LEVEL = 2.4, 2.4, 2.4 MMOL/L MID-LEVEL = 6.4, 6.1, 6.1 MMOL/L IU TESTED THE RETURNED METER USING RETENTION STRIP LOT# 491094 EXP. 12/2013, RETENTION UNIVERSAL ROM KEY CONFIGURATION 112, RETENTION CAL6 SOLUTION, AND THE RETURNED BATTERIES. RESULT: VALUE =15.0 MMOL/L IU PROGRAMMED BOLUS ADVICE WITH CARBS: 10 G BOLUS ADVICE PROVIDED A VALUE OF 10 U IU OBSERVED THE BOLUS AND OBSERVED THE METER DOES PRODUCE A BOLUS REACTION WITH THE RETENTION PUMP AND THE CORRECT BOLUS IS DELIVERED TO THE PUMP. USING A SOLUTION WHICH MIMICS THE NATIVE BLOOD SAMPLE, THE IU WILL BE ABLE TO GENERATE A BG VALUE WHICH WILL PRODUCE A BOLUS ADVICE. THE IU THEN PERFORMED A MANUAL CALCULATION OF THE BOLUS ADVICE (USING THE BG VALUE GENERATED ABOVE) AND VERIFIED THE TWO BOLUS RECOMMENDATIONS WERE IDENTICAL. THIS VERIFIES THAT THE BOLUS CALCULATOR WORKS AS INTENDED. IU WAS ABLE TO VIEW METER'S MEMORY BY ACCESSING THE MY DATA FIELD FROM THE MAIN MENU SCREEN BY PRESSING THE CENTER/SELECT BUTTON ONCE THE FIELD WAS HIGHLIGHTED. IU THEN SELECTED THE VIEW DATA FIELD BY PRESSING THE CENTER/SELECT BUTTON ONCE FIELD WAS HIGHLIGHTED. IU OBSERVED THAT THE LAB RESULT WAS STORED CORRECTLY ALONG WITH THE PROGRAMMED CARB INTAKE AND BOLUS ADVICE PRODUCED. NO LOST OR CHANGED DATA WAS OBSERVED. IU DOWNLOADED THE METER FOR VERIFICATION. METER WAS DOWNLOADED USING RETENTION SOFTWARE: ACCU-CHEK 360 DEGREES VERSION: 1.1. IU OBSERVED 985 RECPRDS SAVED IN MEMORY. IU OBSERVED THAT ALL IN LAB VALUES WERE STORED CORRECTLY IN CHRONOLOGICAL ORDER FROM NEWEST TO OLDEST TEST BY THE REVIEWING THE METER MEMORY; THE SIMULATED BLOOD RESULT WAS STORED CORRECTLY ALONG WITH THE PROGRAMMED CARB INTAKE AND BOLUS ADVICE PRODUCED. NO LOST OR CHANGED DATA WAS OBSERVED. ADDITIONAL FINDING: IU OBSERVED THAT THE METER SERIAL NUMBER LABEL IS FADED AND UNREADABLE DUE TO THE ROBUSTNESS OF THE RIBBON INK. IU DOWNLOADED METER VIA RETENTION ACCU-CHEK SMART PRINTER TO RETRIEVE SERIAL NUMBER FROM MEMORY. METER SN (B)(4). THE SERIAL NUMBER FALLS BELOW THE SERIAL NUMBER CUT OFF ((B)(4)) THAT HAS BEEN KNOWN TO HAVE LABELING ISSUES. THIS TYPE OF DEFECT CAN RESULT IN A LATENT FIELD FAILURE WITH RESPECT TO READING THE SERIAL LABEL AND HAS BEEN INVESTIGATED, A CAPA EXISTS. ALL TESTING PRODUCED ACCEPTABLE RESULTS, NO MALFUNCTION WAS OBSERVED WITH RETURNED METER. THE CUSTOMER'S ALLEGATION OF METER ADDING CARBOHYDRATES BY ITSELF AND INCORRECT BOLUS ADVICE WERE NOT OBSERVED DURING THE INVESTIGATION OF THE RETURNED PRODUCT.

    Description of Event or Problem · 1

    MOTHER REPORTED THE CARBOHYDRATE AMOUNTS ARE AUTOMATICALLY CHANGED IN THE BLOOD GLUCOSE METER/REMOTE AND THIS HAS CAUSED MORE INSULIN TO BE DELIVERED THAN INTENDED. THIS OCCURRED SEVERAL TIMES FROM (B)(6) 2013. ON (B)(6) 2013, MOTHER TESTED PATIENT'S BLOOD GLUCOSE, ENTERED 40 GRAMS OF CARBOHYDRATES, AND CONFIRMED THE BOLUS. SHE THEN ENTERED 60 GRAMS OF CARBOHYDRATES FOR DESSERT AND CONFIRMED ANOTHER BOLUS. PATIENT EXPERIENCED HYPOGLYCEMIA, AND WHEN THE MOTHER REVIEWED THE HISTORY, SHE FOUND THE 60 GRAM ENTRY WAS CHANGED TO 101 GRAMS AND AN ADDITIONAL 120 GRAMS (INCLUDING BOLUS) WERE SHOWN IN THE HISTORY. ON (B)(6) 2013, MOTHER ENTERED 35 GRAMS OF CARBOHYDRATES BEFORE BREAKFAST. SHE VIEWED THE HISTORY AND FOUND THE CARBOHYDRATE AMOUNT HAD AGAIN CHANGED TO 101 GRAMS. THE BOLUS DELIVERED WAS APPROXIMATELY 3 I.U. AND SHOULD HAVE BEEN 1 I.U. PATIENT IS 7 YEARS OLD, AND THE METER IS ALWAYS OPERATED BY AN ADULT. NO DATA HAS BEEN MANUALLY ADDED TO THE HISTORY. NO ERROR MESSAGES WERE DISPLAYED, AND THERE ARE NO ISSUES WITH THE BLUETOOTH COMMUNICATION. THE BLOOD GLUCOSE METER WAS REQUESTED FOR EVALUATION. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106060 ACCU-CHEK ® AVIVA COMBO BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS GMBH 00700006578 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Female