inforMED
MSQ

CARBON 13 TEST

Received Dec 6, 2022 · Event occurred Dec 2, 2022

Report MW5113684 · MDR key 15933221

Device

Generic name

Test, Urea (breath Or Blood)

Manufacturer

Unknown

Product problems

  • Patient-Device Incompatibility

Patient

55 YR · Female

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

Narrative

Description of Event or Problem

PATIENT WAS INTOLERANT TO A CERTAIN TYPE OF CARBON 13 TEST. PROVIDER WASN'T ABLE TO SPECIFY A BRAND. PAE REPORTED BY (B)(6) AT HCP OFFICE. (B)(6) DID NOT CONSENT TO FOLLOW UP. (B)(4).