inforMED
InjuryCGA

TELADOC TEST STRIPS

Received Jul 3, 2025 · Event occurred Jun 16, 2025

Report 3011196194-2025-00063 · MDR key 22396004

Device

Generic name

Test Strips

Catalog number

OFG000016

Lot number

800788;

Product problems

  • Incorrect, Inadequate or Imprecise Result or Readings
  • Low Readings
  • Incorrect, Inadequate or Imprecise Result or Readings
  • Low Readings

Patient

59 YR · Unknown

  • Hypoglycemia
  • Hypoglycemia

Narrative

Additional Manufacturer Narrative

WE FOUND THAT THE PATIENT WAS USING EXPIRED TEST STRIPS. NEW SUPPLIES WERE ORDERED, BUT FOLLOW-UP ATTEMPTS TO CONFIRM TREATMENT AND TROUBLESHOOT WERE UNSUCCESSFUL. THE DEVICE ASSOCIATED WITH THIS INCIDENT WAS NOT RETURNED FOR INVESTIGATION. IF THE DEVICE IS RETURNED AN INVESTIGATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

THE PATIENT REPORTED LOW BLOOD GLUCOSE READINGS. THE PATIENT WENT TO THE EMERGENCY ROOM SEEKING MEDICAL ATTENTION DUE TO THEIR READING NOT RISING AND REMAINING LOW.