BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK PERFORMA COMBO

    MDR report key: 2932120 · Received January 18, 2013

    Report

    Report Number
    2183996-2012-02213
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 10, 2012
    Report Date
    May 10, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE OF THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION; THEREFORE, AN INVESTIGATION COULD NOT BE PERFORMED. DEVICE WAS NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON (B)(6) 2012, PATIENT REPORTED RECEIVING AN E7 (ELECTRONIC ERROR) MESSAGE ON THE INFUSION DEVICE TWICE. PATIENT STATED BOTH TIMES THE INCIDENT OCCURRED; THE INFUSION DEVICE DID NOT VIBRATE BUT MADE A FUNNY BEEP THEN GAVE AN ERROR. PATIENT STATED HE TOOK THE BATTERY OUT AND REINSERTED IT; THE INFUSION DEVICE IS WORKING FINE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. SENDING BATTERY COVER; INFUSION DEVICE WAS NOT REQUESTED TO BE RETURNED FOR EVALUATION. ON (B)(6) 2012 PATIENT REPORTED RECEIVING AN E7 (ELECTRONIC ERROR) MESSAGE ON THE INFUSION DEVICE TWICE. PATIENT STATED BOTH TIMES THE INCIDENT OCCURRED; THE INFUSION DEVICE DID NOT VIBRATE BUT MADE A FUNNY BEEP THEN GAVE AN ERROR. PATIENT STATED HE TOOK THE BATTERY OUT AND REINSERTED IT; THE INFUSION DEVICE IS WORKING FINE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. SENDING BATTERY COVER; INFUSION DEVICE WAS NOT REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28628 ACCU-CHEK PERFORMA COMBO LZG ROCHE HEALTH SOLUTIONS INC. 05987288020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR RELATED ACCESSORIES| INSULIN| INSULIN INFUSION PUMP