MalfunctionCFR
ALINITY C GLUCOSE REAGENT KIT
Received Jul 6, 2026 · Event occurred Jun 22, 2026
Report 3002809144-2026-00175 · MDR key 25722685
Device
Product problems
- Low Test Results
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY DECREASED GLUCOSE RESULTS GENERATED FROM ALINITY C PROCESSING MODULE FOR A MALE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2026, SID (B)(6), INITIAL=36 MG/DL /REPEATED=216 MG/DL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.