BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1911929 · Received December 1, 2010

    Report

    Report Number
    1823260-2010-07074
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 6, 2010
    Report Date
    January 7, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE INFORM SYSTEM WITHIN 10 MINUTES: 34 MG/DL AND 125 MG/DL. CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT ROCHE METERS, WITHIN 10 MINUTES: 34 MG/DL, 125 MG/DL (INFORM (B)(4)) AND 114 MG/DL (INFORM (B)(4)) CALLER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON AN INFORM METER, COMPARED TO LAB RESULTS, WITHIN 10 MINUTES: 34 MG/DL (METER); 100 MG/DL (LAB). READINGS OF 34 MG/DL AND 125 MG/DL WERE TAKEN ONLY ONE TIME - NO DUPLICATION OF READINGS. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    TIBIAL IMPACTOR TIP BROKE OFF INSIDE THE IMPACTOR HANDLE. THERE WAS NO DELAY IN SURGERY OR ADVERSE IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS 551210

    Patients

    Seq Age Sex Outcome Treatment
    1 066 YR DEXMEDETOMIDINE| ASPIRIN| NACL 0.9%| INFLUENZA VIRUS TRIV| PROPOFOL| VECUROMIUM BROMIDE| MEROPENEM| ACETAMINOPHEN| 0.45% SODIUM CHLORIDE| KCL| INSULIN REO HUMAN| FUROSEMIDE| LABETALOL HCL| METOCLOPRAMIDE HCL| LIDOCAINE HCL 4%| ETOMIDATE| DIPHENHYDRAMINE| DEXTROSE| HYDRALAZINE| SODIUM BICARB| POVIDONE-IODINE 10%| HEPARIN SODIUM| MICONAZOLE NITRATE| METOPROLOL TARTRATE| MAGNESIUM SULFATE| D5W 0.9NS| D50W| CEFTRIAXONE SODIUM| CARVEDILOL| BARIUM SULFATE| AMLODIPINE BESYLATE| ALBUTEROL SULFATE| ALBUMIN 5%| LISPRO| INSULIN GLARGINE| PRE-MIX DEXTROSE| PAPAIN/UREA| OVRFIL| OXYCODONE/APAP| MORPHINE SULFATE| LINEXOLID| ONDANSETRON HCL| ENOXAPARIN| HUMULIN N| CLONIDINE HCL| NA/K BIPHOSPHATE| IPRATROPIUM BROMIDE| HYDROMORPHONE HCL| LEVOFLOXACIN/DEXTROSE| PANTOPRAZOLE SODIUM| LORAZEPAM| GLUCAGON| MAGNESIUM OXIDE| BUMETANIDE| VANCOMYCIN HCL| CADEXOMER IODINE| INSULIN ASPART