TELADOC BLOOD PRESSURE MONITOR

Description of Event or Problem

EVENT OR PROBLEM DESCRIPTION: THE PATIENT REPORTED INACCURATE READINGS FROM THEIR TELADOC BLOOD PRESSURE MONITOR. THE TELADOC MONITOR READINGS WERE APPROXIMATELY 30 POINTS HIGHER COMPARED TO READINGS OBTAINED USING THE DOCTOR'S MANUAL PUMP MONITOR. THE MEASUREMENTS WERE TAKEN 1-3 MINUTES APART ON EACH ARM. NO MEDICAL TREATMENT WAS REPORTED IN CONNECTION WITH THE DEVICE MALFUNCTION. ADDITIONAL MANUFACTURER NARRATIVE: (PROVIDED BY TELADOC). THE DEVICE RELATED TO THIS INCIDENT WAS RETURNED FOR INVESTIGATION. INTERNAL FUNCTIONAL TESTING WAS PERFORMED, AND NO FAILURES WERE DETECTED DURING FUNCTIONAL TESTING. THE INTERNAL INVESTIGATION CONFIRMED THE DEVICE WAS WORKING AS INTENDED.

Additional Manufacturer Narrative

CAUSE: OUR IMPORTER TELADOC CONDUCTED AN INVESTIGATION OF THE ORIGINAL BLOOD PRESSURE MONITOR AND FOUND NO ISSUES. THE DEVICE PERFORMED WITHIN ITS SPECIFIED ACCURACY RANGE. FOR TRANSTEK, THERE ARE SOME SIMILAR CLAIMS FROM OTHER FEEDBACKS AND THE CAUSE ANALYSIS SHOULD BE THE SAME THEORETICALLY AS BELOW. 1. WE CHECKED THE ALL RELATED DHR, INCLUDING MANUFACTURED PROCESS RECORDS, FQC INSPECTION RECORDS, ECT, AND NO ACCURACY ISSUE WAS FOUND. 2. THE PRODUCT HAS PASSED CLINICAL VALIDATION ISO 81060-2:2018. ITS PERFORMANCE MEETS THE REQUIREMENTS. 3. THE INSTRUCTIONS HAVE ALREADY COVERED THE RELEVANT OPERATION. THE CUSTOMER MIGHT NOT READ THE INSTRUCTIONS CAREFULLY. CORRECTIVE ACTION: PREPARE A DOCUMENT CONCERNING TROUBLESHOOTING AND ESSENTIAL PRECAUTIONS AS A NOTIFICATION OF REMINDER FOR CUSTOMER PROMOTION TO MINIMIZE THE RISK OF USER MISOPERATIONS. CONCLUSION: THIS ISSUE WOULD NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, NOT A MDR EVENT.