BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA TEST STRIPS

    MDR report key: 1841749 · Received September 22, 2010

    Report

    Report Number
    1823260-2010-05634
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 31, 2010
    Report Date
    November 19, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING THE CUSTOMER'S REPORTED ISSUE HOMECHOICE (HC) MACHINE NOT DRAINING HIM DURING INITIAL DRAIN, THE HOME PATIENT (HP) REVEALED THAT THE HC MACHINE DID NOT ALARM EITHER THE HP ADDED THAT DURING THE INITIAL DRAIN THE NUMBERS HOVER BETWEEN 26 ML AND BACK TO 17 ML. THE HP HAD A LAST FILL OF 2 L AND THE INITIAL DRAIN ALARM IS SET TO 1200 ML. THE HP HAD BEEN HAVING THIS PROBLEM SINCE THE PAST THREE NIGHTS AND ADDED THAT HE END UP GETTING OFF THE HC MACHINE AND USE MANUAL SUPPLIES. PER INITIAL REPORT, THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ARRANGED A SWAP OF THE INSTRUMENT DUE TO THIS ISSUE. THE HP WOULD CALL THE NURSE REGARDING MISSED THERAPY AND THE SWAP OF THE HC MACHINE. DURING A FOLLOW UP WITH THE HP REGARDING THE REPORTED ISSUE, IT WAS REVEALED THAT THE ISSUE HAD BEEN RESOLVED SINCE THE HC MACHINE WAS REPLACED. THE HP EXPLAINED THAT THE TWO NIGHTS PRIOR TO THE TIME HE HAD CALLED BAXTER WAS THE SAME ISSUE IN TERMS OF HP NOT DRAINING ENOUGH AND THE HC MACHINE CONTINUING WITHOUT ALARMING. THE HP'S PRESCRIBED FILL VOLUME IS 2500 ML. THE HP DID NOT REMEMBER THE EXACT AMOUNT OF FLUID HE DRAINED MANUALLY BECAUSE OF THE VERY LITTLE INITIAL DRAIN. HOWEVER, THE HP VERIFIED THAT THE MANUAL DRAIN AMOUNT DID NOT EXCEED 2500 ML. THE HP STATED THAT HE IS DOING FINE AND CONTINUING THERAPY WITHOUT ANY FURTHER ISSUES. THE HP STATED THAT HE DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 425 MG/DL AND 166 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 302614

    Patients

    Seq Age Sex Outcome Treatment
    1 086 YR LUMIGAN| ENABLEX| CITALOPRAM ONCE DAILY| THIORIDAZINE| TIMOLOL| AMLODIPINE| FUROSEMIDE| NOVOLOG 70/30| WHEELCHAIR| WALKER| HOSPITAL BED| WARFARIN SODIUM| LISINOPRIL HCTZ| MECLIZINE| LOPERAMIDE| PROPOXYPHENE| PROAIR HFA| "ENABALIZER"| NEXIUM ONCE DAILY