BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® PERFORMA TEST STRIPS

    MDR report key: 1932690 · Received December 20, 2010

    Report

    Report Number
    1823260-2010-07547
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 24, 2010
    Report Date
    March 30, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CALLER STATES PATIENT TESTED 10.6 MMOL/L ON THE PERFORMA SYSTEM AT 01:59 AND WAS TREATED WITH "NOVOLIN" BASED ON THIS RESULT. LAB RESULT OF 1.5 MMOL/L RETURNED AT 02:29 AND INSULIN WAS DISCONTINUED. AT 03:41 PATIENT TESTED 1.4 MMOL/L ON A LAB VALUE AND AT THE SAME TIME 6.1 MMOL/L ON THE PERFORMA SYSTEM. CALLER DID NOT PROVIDE TREATMENT INFORMATION. NO ADVERSE EVENT RELATED TO THE DEVICE WAS REPORTED. REQUESTED RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® PERFORMA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 370216

    Patients

    Seq Age Sex Outcome Treatment
    1 057 YR AMBROXOL HYDROCHLORIDE IV| MINOCYCLINE HCL| NIFEDIPINE| MILRINONE IV| TORSEMIDE IV| LEVOFLOXACIN HYDROCHLORIDE IV| ISOSORBIDE DINITRATE IV| MEGLUMINE ADENOSINE| B. LICHENIFORMIS| CLOPIDOGREL BISULFATE| ISOSORBIDE MONONITRATE| VENTILATOR| METOPROLOL TARTRATE| ALUMINIUM PHOSPHATE GEL| LACIDOPHILIN| ENTERIC COATED ASPIRIN