COBAS® PCR MEDIA UNI SWAB SAMPLE KIT

Additional Manufacturer Narrative

INVESTIGATION OF THE KIT DID NOT IDENTIFY ANY ISSUE. THE CUSTOMER INDICATED THE SWAB WAS INTACT WHEN THE CUSTOMER RECEIVED THE PRODUCT. THE COBAS® PCR MEDIA UNI SWAB KIT INSTRUCTIONS FOR USE (IFU) REFERS TO THE ASSAY SPECIFIC INSTRUCTIONS ON SWAB COLLECTIONS. ACCORDING TO THE COBAS® CT/NG IFU, THE ANORECTAL SWAB SPECIMENS SHOULD BE COLLECTED BY CLINICIANS. IN THIS CASE, THE PATIENTS WERE INSTRUCTED BY THE CLINICIANS AND PERFORMED SELF-COLLECTION, WHICH WAS NOT INDICATED IN THE PRODUCT'S IFU AND MOST LIKELY THE REASON FOR THE SWABS BREAKING. (B)(4).

Description of Event or Problem

A CUSTOMER ALLEGED TWO INCIDENTS WHEN THE WOVEN SWAB, WHICH IS PACKAGED IN THE COBAS® PCR MEDIA UNI SWAB SAMPLE KIT, BROKE OFF PREMATURELY DURING A RECTAL SELF-COLLECTION, FOR CT/NG TESTING, INSTRUCTED BY THE CLINICIAN. ONE OF THE PATIENTS WAS ABLE TO REMOVE THE BROKEN SWAB BY THEMSELVES. THE SECOND PATIENT HAD THE SWAB REMOVED IN THE EMERGENCY ROOM. IT IS UNKNOWN IF THE PATIENT HAD TO STAY IN THE HOSPITAL. IT IS ALSO UNKNOWN IF THE PATIENT WAS INJURED DURING THE INCIDENT. THE PATIENT REFUSED ANY FURTHER CONTACT WITH THE CLINIC. THE CUSTOMER INDICATED THE SWAB WAS INTACT WHEN THE CUSTOMER RECEIVED THE PRODUCT. THE COBAS® PCR MEDIA UNI SWAB KIT INSTRUCTIONS FOR USE (IFU) REFERS TO THE ASSAY SPECIFIC INSTRUCTIONS ON SWAB COLLECTIONS. ACCORDING TO THE COBAS® CT/NG IFU, THE ANORECTAL SWAB SPECIMENS SHOULD BE COLLECTED BY CLINICIANS. IN THIS CASE, THE PATIENTS WERE INSTRUCTED BY THE CLINICIANS AND PERFORMED SELF-COLLECTION, WHICH WAS NOT INDICATED IN THE PRODUCT'S IFU AND MOST LIKELY THE REASON FOR THE SWABS BREAKING.