BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1052033 · Received May 21, 2008

    Report

    Report Number
    1823260-2008-04182
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    April 18, 2008
    Report Date
    May 21, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS BACK TO BACK RESULTS OF HI (GREATER THAN 600MG/DL) AND 156MG/DL WHILE USING THE INFORM SYS. CALLER REPORTS PT RECEIVED NO TREATMENT BASED ON METER READINGS. CALLER REPORTS QUALITY CONTROLS HAVE BEEN PASSING. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 550512

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR LIPITOR 10MG TABLET| BENADRYL 50MG/ML VIA| LOVENOX 40MG PREFILL| IV FAMOTIDINE 20MG/2| DILTIAZEM 125MG/25ML| LANOXIN 0.125MG| EVACUATED CONTAINER D5-1/2NS/KCL 20MEQ/L| BUMETANIDE 0.5MG TAB| CLINIMIX 5/15 SOLUTI| METOPROLOL 5MG/5ML S| TOPROL XL 50MG TAB| MEGESTROL 40MG/ML OR| TPN ELECTROLYTE SOLU| XYLOCAINE SOLUTION 4| XYL JELLY (OR)| TRANDATE 5MG/ML (OR)| GLYCOPYRROLATE 0.2MG| LACTATED RINGERS INJ| PROPOFOL 1000MG/100M| COUMADIN 5MG TAB| MULTE-PAK-4 VIAL| LEVOTHYROXINE 0.05MG| SUCCINYLCHOLINE 200M| SOTALOL 80MG TAB| SIMVASTATIN 40MG TAB| ROCURONIUM 50MG/5 ML| FUROSEMIDE 20MG/2ML| FENTANYL 250MCG/5ML| KETOROLAC 15MG/ML VI| NOVOLIN R VIAL 1UNIT| ALBUTEROL .83MG/ML S| ZOSYN 3.375G/50ML| PROTONIX 40 MG TAB| ETOMIDATE 20MG SDV 1| NIFEDIPINE XL 30MG T| COUMADIN TEACHING PA| NEOSTIGMINE 1:1000V| NALOXONE 0.4MG/ML AM| SODIUM CHLORIDE 0.9%| M.V.I. ADULT VIAL| MIDAZOLAM 2MG/2ML VI| HYDROMORPHONE 1MG/ML| LORAZEPAM 2MG/ML| CEFAZOLIN 1GM VIAL| CILOSTAZOL 50MG TAB| HYDROCHLOROTHIAZIDE ISOPTO TEARS 0.5% EY| GRANULEX SPRAY| MAGNESIUM SULFATE 50| POTASSIUM PH 3MM/ML| INTRALIPID 20% IV FA| METRONIDAZOLE 500MG| PROTONIX IV 40MG| POTASSIUM CL 20MEQ/1| ONDANSETRON 2MG/ML 2| MAGNESIUM SULFATE 2G| PROPOXY-N/APAP 100-6| HYDRALAZINE 20MG/ML| PLAVIX 75MG TAB| ACEPHEN 650MG SUPPOS| NITRO-BID 2% OINTMENT| MORPHINE 4MG/ML CARP| ASPIRIN 81MG TAB| DOPAMINE 1600 MCG/1| CEFAZOLIN 1GM/D5W BA