BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIRECTCHECK NORMAL ACT+

    MDR report key: 6071539 · Received November 1, 2016

    Report

    Report Number
    3002721930-2016-00013
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Date of Event
    October 26, 2016
    Report Date
    October 31, 2016
    Manufacturer
    ACCRIVA DIAGNOSTICS
    Product Code
    GGN
    PMA / PMN Number
    K120977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR SUBMITTED ON 11/01/2016 REFERENCES ACCRIVA DIAGNOSTICS COMPLAINT NUMBER (B)(4). METHOD: ACTUAL DEVICE NOT EVALUATED. PROCESS EVALUATION WAS NOT PERFORMED AS THE COMPLAINT IS NOT RELATED TO PRODUCT PERFORMANCE OR PACKAGING. NO TESTING METHODS PERFORMED. RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. CONCLUSIONS: HUMAN FACTORS ISSUE. TRAINING DEFICIENCY. DEVICE NOT RETURNED. SINCE THIS COMPLAINT IS NOT RELATED TO PRODUCT PERFORMANCE AND THE DEVICE WILL NOT BE EVALUATED, THIS SUBMISSION IS CONSIDERED A FINAL REPORT. ACCRIVA DIAGNOSTICS HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED THAT AN END USER SUSTAINED A CUT DURING RECONSTITUTION OF A DIRECTCHECK QUALITY CONTROL. THIS CONTROL IS PACKAGED IN A GLASS AMPULE INSIDE A CRUSHABLE PLASTIC DROPPER VIAL THAT CONTAINS DILUENT. THE END USER WAS WEARING GLOVES, BUT IT WAS NOT KNOWN IF THE END USER WAS USING THE PROTECTIVE SLEEVE PROVIDED WITH THE PRODUCT. THE PURPOSE OF THE SLEEVE IS TO SAFEGUARD THE END USER AGAINST POTENTIAL INJURY DURING RECONSTITUTION OF THE CONTROL. AFTER CRUSHING THE VIAL, A GLASS SHARD PROTRUDED THROUGH THE DROPPER VIAL AND CAUSED A SMALL LACERATION ON THE USER'S RIGHT INDEX FINGER. THE END USER IMMEDIATELY WASHED THE AREA WITH SOAP AND WATER AND COVERED THE CUT WITH A (B)(6). NO SIGNIFICANT BLOOD LOSS OR MEDICAL COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721573 DIRECTCHECK NORMAL ACT+ DCJACT-N GGN ACCRIVA DIAGNOSTICS DCJACT-N D6DNA011

    Patients

    Seq Age Sex Outcome Treatment
    1