BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1863923 · Received October 11, 2010

    Report

    Report Number
    1823260-2010-06048
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    October 6, 2010
    Report Date
    November 15, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    DISCOMFORT [MUSCULOSKELETAL DISCOMFORT], ANAPHYLAXIS [ANAPHYLACTIC REACTION], RED KNEE [ERYTHEMA], WARM KNEE [JOINT WARMTH], EFFUSION COLLECTED BEFORE SECOND INJECTION [JOINT EFFUSION], SWOLLEN KNEE [JOINT SWELLING]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON (B)(6) 2010 FROM A PHYSICIAN VIA A GENZYME COMPANY REP REGARDING A MALE PT, INITIALS (B)(6), WITH A MEDICAL HISTORY OF OSTEOARTHRITIS RIGHT KNEE AND PREVIOUS SYNVISC USE "MULTIPLE TIMES." THE PT WAS ADMINISTERED THE SYNVISC SERIES ON AN UNK DATE IN (B)(6) 2010, THE SECOND INJECTION ON (B)(6) 2010. THE PT EXPERIENCED DISCOMFORT ON AN UNK DATE IN (B)(6) 2010. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE REPORTED EVENT AND TREATMENT WERE UNK. SYNVISC LOT NUMBER WAS N1003. NO FURTHER INFO WAS PROVIDED. ADDITIONAL INFO WAS RECEIVED ON (B)(6) 2010 FROM THE PHYSICIAN. THE (B)(6) PT HAD ADDITIONAL MEDICAL HISTORY OF PREVIOUS TREATMENT WITH NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) AND PRIOR EFFUSION. PRIOR TO THE PT'S FIRST INJECTION WITH SYNVISC ON (B)(6) 2010 IN THE RIGHT KNEE, 1 ML OF EFFUSION WAS COLLECTED BUT ANALYSIS WAS NOT PERFORMED. PRIOR TO THE PT'S SECOND INJECTION WITH SYNVISC IN THE RIGHT KNEE, 1 ML OF EFFUSION WAS COLLECTED. THE ONSET DATE OF THE EVENT DISCOMFORT WAS (B)(6) 2010. THE PHYSICIAN STATED THAT ANAPHYLAXIS WAS DUE TO THE PREVIOUS SYNVISC INJECTION. THE KNEE WAS DESCRIBED AS RED, SWOLLEN, AND WARM. FLUID WAS ASPIRATED AND TREATMENT INCLUDED A CORTISONE INJECTION. ALL EVENTS WERE RECOVERED ON AN UNK DATE IN 2010. THE RELATION OF THE EVENT DISCOMFORT TO SYNVISC INJECTION WAS PROBABLE AND THE PHYSICIAN STATED THAT THE FIRST INJECTION OF SYNVISC WAS A POSSIBLE PRECIPITATING EVENT. THE INTENSITY OF THE SYMPTOM WAS SEVERE. THE QA (QUALITY ASSURANCE) INVESTIGATION RESULTS WERE RECEIVED ON (B)(6) 2010. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT NUMBER N1003, EXPIRY DATE 12/2012 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF HI (GREATER THEN 600 MG/DL) AND 244 MG/DL WITHIN 10 MINUTES ON THE AVIVA SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS 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 302716

    Patients

    Seq Age Sex Outcome Treatment
    1 083 YR NOVOLOG| GEMFIBROZIL| METOCLOPRAMIDE| BOOST| LACTULOSE 10GM/15ML| LOVASTATIN| MIRTAZAPINE| LORAZEPAM| OXYCODONE "IR"| LANTUS SOLOSTAR| OXYCONTIN| OMEPRAZOLE| MIDODRINE| VIOKASE| CENTRUM SILVER