MalfunctionCGA
MEDLINE
Received Jun 10, 2026 · Event occurred May 12, 2026
Report 1417592-2026-02336 · MDR key 25457436
Device
Generic name
Strip,glucose,evencare G3,prof.use Only
Manufacturer
Medline Industries, LpCatalog number
MPH3550Z
Product problems
- High Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE DEVICE IS PRODUCING FALSE HIGH READINGS. 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.
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE IS PRODUCING FALSE HIGH READINGS.