COMBUR 9 TEST
Received Jan 12, 2026 · Event occurred Dec 12, 2025
Report 1823260-2026-00136 · MDR key 24037229
Device
Generic name
Urine Test Strips
Manufacturer
Roche DiagnosticsCatalog number
04510038191
Lot number
86071601
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SECTIONS D9 AND H3 WERE UPDATED. THE CUSTOMER'S TEST STRIPS WERE RECEIVED FOR INVESTIGATION. THE RETENTION AND CUSTOMER MATERIALS SHOWS NO FALSE NEGATIVE RESULTS AND PERFORMED WITHIN SPECIFICATION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE COMBUR 9 TEST RESULTS FOR 1 PATIENT. THE REPORTER STATED THAT THE PATIENT ALLEGED THAT THEY PURCHASED THE URINE STRIPS FOR HOME URINE DIPSTICK TESTING. THE TEST STRIP ONLY GAVE A POSITIVE RESULT FOR BLOOD, AND WHEN THEY WENT TO THE HOSPITAL 12 HOURS LATER, A URINE DIPSTICK TEST WAS PERFORMED, WHICH WAS POSITIVE FOR LEUKOCYTES, BILIRUBIN, AND BLOOD.
Additional Manufacturer Narrative
THE CUSTOMER'S STRIPS WERE REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.