MalfunctionFLL
MEDLINE
Received May 31, 2026 · Event occurred May 4, 2026
Report 1417592-2026-01933 · MDR key 25342692
Device
Product problems
- No Device Output
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE DOES NOT PRODUCE A READING.
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE DEVICE DOES NOT PRODUCE A READING. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.