DIRECTCHECK ACT-LR QUALITY CONTROL, NORMAL

Additional Manufacturer Narrative

THIS MDR SUBMITTED ELECTRONICALLY ON 05/11/2018 REFERENCES ACCRIVA DIAGNOSTICS' COMPLAINT NUMBER (B)(4). METHOD CODE: ACTUAL DEVICE NOT EVALUATED. DHR REVIEW WAS NOT PERFORMED BECAUSE THE COMPLAINT IS UNRELATED TO PRODUCT PERFORMANCE OR PACKAGING. RESULTS CODE: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. CONCLUSION CODES: HUMAN FACTORS ISSUE. TRAINING DEFICIENCY. DEVICE NOT RETURNED. ACCRIVA DIAGNOSTICS HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A. FIELDS FOR WHICH DATA WERE NOT OBTAINABLE OR ARE NOT APPLICABLE ARE INTENTIONALLY LEFT BLANK.

Description of Event or Problem

HEALTHCARE PROFESSIONAL REPORTED THAT AN END USER SUSTAINED AN INJURY WHILE HANDLING A DIRECTCHECK QUALITY CONTROL. THIS CONTROL IS PACKAGED IN A GLASS AMPULE INSIDE A CRUSHABLE PLASTIC DROPPER VIAL CONTAINING DILUENT. THE END USER CRUSHED THE VIAL TO RECONSTITUTE THE CONTROL AND SUSTAINED A SMALL CUT TO HER RIGHT INDEX FINGER WHICH WAS CAUSED BY A SHARD OF GLASS. THE END-USER WORE GLOVES BUT FAILED TO UTILIZE THE PROTECTIVE SLEEVE PROVIDED WITH THE PRODUCT . THE PURPOSE OF THE SLEEVE IS TO SAFEGUARD THE END USER AGAINST POTENTIAL INJURY WHILE HANDLING THE CONTROL. THE END USER FILED A REPORT WITH HER SUPERVISOR AND WAS SEEN BY OCCUPATIONAL HEALTH. NO LAB TESTS WERE DRAWN AND GENERAL SITE CARE WAS PERFORMED. THE NEXT DAY, THE END USER FOLLOWED UP WITH OCCUPATIONAL HEALTH. THE PUNCTURE SITE SHOWED NO PROBLEMS AND WAS HEALING.