BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 2040156 · Received April 5, 2011

    Report

    Report Number
    1823260-2011-01883
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    November 8, 2010
    Report Date
    May 12, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1 (LOT NUMBER 277036, EXPIRATION DATE 07/31/2011). REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) FOR THE SUSPECT DEVICE USED IN SYSTEM 2.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1 (LOT NUMBER 277036, EXPIRATION DATE 07/31/2011). REFERENCE MEDWATCH REPORT WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE SUSPECT DEVICE USED IN SYSTEM 2. ADDITIONAL INFORMATION PROVIDED FOR REVIEW ON (B)(6) 2011. THE INFORMATION PROVIDED INDICATED THAT THERE WAS NO SERIOUS INJURY WITH THIS ALLEGATION.

    Description of Event or Problem · 1

    CALLER STATES CUSTOMER TESTED WITH ONE OF HER MOBILE SYSTEMS (DID NOT RECALL WHICH ONE) AND OBTAINED A RESULT SHE DID NOT RECALL. BASED UPON THE RESULT OBTAINED, SHE ADJUSTED HER INSULIN PUMP DELIVERY (DETAILS NOT PROVIDED). AFTER FIVE MINUTES, SHE HAD CONVULSIONS AND PASSED OUT FOR 3 TO 6 MINUTES. AFTER SHE HAD PASSED OUT, CALLER OBTAINED BLOOD GLUCOSE RESULTS OF 4.1 MMOL/L ON MOBILE SYSTEM 1, 4.1 MMOL/L ON MOBILE SYSTEM 2, AND 1.2 MMOL/L ON A CONTOUR SYSTEM. CALLER TREATED CUSTOMER WITH GLUCOGEL, AND CUSTOMER CONSUMED YOGURT AND (B)(6) AN HOUR LATER.

    Description of Event or Problem · 1

    CALLER STATES CUSTOMER TESTED 4.1 MMOL/L ON MOBILE SYSTEM 1 AND 4.1 MMOL/L ON MOBILE SYSTEM 2 AND BEGAN HAVING CONVULSIONS 5 MINUTES LATER AND PASSED OUT. CUSTOMER WAS UNCONSCIOUS FOR 60 MINUTES. CALLER TESTED CUSTOMER ON THE MOBILE SYSTEM AND RECEIVED RESULT OF 4.1 MMOL/L (CALLER DID NOT INDICATE WHICH SYSTEM THIS RESULT WAS OBTAINED ON); CALLER RE- TESTED THE CUSTOMER ON HER CONTOUR SYSTEM AND OBTAINED A RESULT OF 1.2 MMOL/L. CALLER TREATED THE CUSTOMER WITH GLUCOSE GEL AND THE CUSTOMER STABILIZED. REQUESTED RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 277036

    Patients

    Seq Age Sex Outcome Treatment
    1 012 YR Required Intervention UNKNOWN INSULIN PUMP| BAYER CONTOUR METER| UNKNOWN INSULIN