BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1832522 · Received September 13, 2010

    Report

    Report Number
    1823260-2010-05395
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    September 2, 2010
    Report Date
    October 7, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE FIELD APPLICATION SPECIALIST REPORTED THE USER RECEIVED QUESTIONABLE SODIUM RESULTS FOR ONE PATIENT SAMPLE FROM THE INTEGRA 800 SERIAL NUMBER (B)(4). THE ORIGINAL RESULT WAS 128 MMOL/L. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER WITH RESULTS OF 133, 131, 127, 127, 126, AND 127 MMOL/L. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER IN A SAMPLE CUP WITH RESULTS OF 132, 127, 127, 127 AND 127 MMOL/L. THE SAMPLE WAS THEN REPEATED ON INTEGRA 800 SERIAL NUMBER (B)(4) WITH RESULTS OF 132, 132, 132, 132 AND 132 MMOL/L. THE PATIENT WAS NOT TREATED BASED ON THE ORIGINAL RESULT AS IT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE RESULT OF 132 MMOL/L FROM ANALYZER (B)(4) WAS REPORTED OUTSIDE THE LABORATORY. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A DEFECTIVE SODIUM ELECTRODE AND FOUND A "BUMP" OF MATERIAL NEXT TO THE FLOW PATH HOLE ON THE ELECTRODE. THIS BUMP LOOKED TO BE PLASTIC OR A GLUE OF SOME SORT. WHEN THE O-RING FROM THE ADJOINING ELECTRODE WOULD PRESS AGAINST THIS ELECTRODE, THE BUMP WOULD NOT CREATE A GOOD SEAL CAUSING LEAKAGE. HE REPLACED THE ELECTRODE AND THE MIX TOWER AND CHECKED THE ISE OPERATION, HE VERIFIED THE ANALYZER OPERATION BY RUNNING ISE PERFORMANCE CHECKS, CALIBRATION, QUALITY CONTROL AND A PRECISION CHECK. THE FIELD APPLICATION SPECIALIST COULD NOT DETERMINE A CAUSE. SHE VERIFIED THE CALIBRATION AND QUALITY CONTROL RESULTS AND EXAMINED THE SAMPLE. SHE FOUND THE SAMPLE WAS FREE OF FIBRIN, DEBRIS, HEMOLOSIS, LIPEMIA AND ICTERUS. PRECISION TESTING, CALIBRATION AND QUALITY CONTROL WERE ALL ACCEPTABLE AND THE ANALYZER WAS OPERATING AS EXPECTED AND WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AVIVA RESULTS OF 468 MG/DL, 1 MINUTE LATER 142 MG/DL, 2 MINUTES LATER 130 MG/DL, 4 MINUTES LATER 123 MG/DL. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 302320

    Patients

    Seq Age Sex Outcome Treatment
    1 054 YR THEOPHYLLINE 2XDAY| HYDROCHLOROTHIAZIDE 1XDAY| ZOCOR 1XDAY| ZOLOFT 1XDAY| WELLBUTRIN 1XDAY| GEODON| PROPANOLOL 2XDAY| IBUPROFEN 3XDAY| DILTIAZEM| METFORMIN 3XDAY| NEBULIZER