MEDLINE

Description of Event or Problem

THE REPORT STATES, "CUSTOMER CALLED IN STATING HIS BLOOD PRESSURE MONITOR IS GIVING READINGS THAT ARE INACCURATE AND ARE WAY OFF FROM THE READINGS OBTAINED AT THE DOCTOR."

Additional Manufacturer Narrative

THE REPORT STATES, "CUSTOMER CALLED IN STATING HIS BLOOD PRESSURE MONITOR IS GIVING READINGS THAT ARE INACCURATE AND ARE WAY OFF FROM THE READINGS OBTAINED AT THE DOCTOR. WE TOOK THE UNIT TO OUR PCP TO DO A COMPARISON. THE RESULTS BETWEEN THEIR PROFESSIONAL UNIT AND OUR MEDLINE RESULTED WITH A BLOOD PRESSURE DIFFERENCE. OUR PRIMARY CARE PHYSICIAN (PCP) WAITED 10 MIN AND RETESTED TO COMPARE WITH SIMILAR RESULTS." CUSTOMER ALSO REPORTED THAT PATIENT IS FINE AND AFTER VERIFYING THE RESULTS, THE PATIENT'S MEDICATION DID NOT REQUIRE ANY ADJUSTMENTS AT THIS TIME. 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 MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.