COBAS® PCR MEDIA UNI SWAB SAMPLE KIT

Description of Event or Problem

A CUSTOMER ALLEGED THAT A SWAB, WHICH IS PACKAGED IN THE COBAS® PCR MEDIA UNI SWAB SAMPLE KIT, BROKE DURING SAMPLE COLLECTION. THE PATIENT WAS ALLEGEDLY COLLECTING AN ANORECTAL SAMPLE AND THE SWAB BROKE DURING SELF-COLLECTION. PART OF THE SWAB WAS LODGED IN THE PATIENT¿S RECTUM. THE PATIENT REPORTEDLY WENT TO THE EMERGENCY ROOM TO HAVE THE SWAB FRAGMENT REMOVED. IT COULD NOT BE CONFIRMED WHAT TREATMENT THE PATIENT RECEIVED OR IF THEY WERE ADMITTED. NO FURTHER HARM WAS REPORTED.

Additional Manufacturer Narrative

THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. AN OFF-LABEL SAMPLE COLLECTION WAS PERFORMED. PER THE OPERATOR'S MANUAL, ANORECTAL SWAB COLLECTIONS ARE INTENDED TO BE PERFORMED BY A CLINICIAN. IT IS POSSIBLE THAT THE PATIENT ACCIDENTALLY BROKE THE SWAB AT THE SHORELINE DURING COLLECTION, RESULTING IN THE SWAB GETTING LODGED IN THE RECTUM DURING SELF-COLLECTION.