TELADOC TEST STRIPS

Additional Manufacturer Narrative

MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE PATIENT TO TROUBLESHOOT FURTHER WITH NO SUCCESS. A REFILL KIT AND CONTROL SOLUTION WERE SENT TO THE PATIENT. THE PATIENT'S TEST STRIPS WERE REQUESTED TO BE RETURNED FOR INVESTIGATION. IF THE TEST STRIPS ARE RETURNED AN INVESTIGATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

THE PATIENT REPORTED THAT THEY WERE RECEIVING LOW READINGS, IN THE 40S AND INDICATED THAT THEY FELT FINE. THE PATIENT STATED THAT THEY KNEW THE LOW READINGS WERE NOT CORRECT, BUT FELT NERVOUS, AND CONSUMED GLUCOSE TABLETS. THEY ALSO ADJUSTED THEIR INSULIN BASED ON THESE READINGS. THE PATIENT ALSO REPORTED THAT THEY CHECKED THEIR BLOOD GLUCOSE RIGHT BEFORE GETTING BLOOD WORK DONE AND THEIR TELADOC METER RESULTS WERE INCONSISTENT WITH THE LAB TEST RESULTS. THE TELADOC BLOOD GLUCOSE METER READING WAS 91 AND THE LAB TEST RESULT WAS 160.