LIVONGO TEST STRIPS

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED, HOWEVER, IF THE DEVICE WERE RETURNED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

PATIENT REPORTED CHECKING THEIR BLOOD GLUCOSE LEVELS MULTIPLE TIMES WITH THE LIVONGO METER, AND THE RESULTS WERE 53 AND 66. THE PATIENT'S SYMPTOMS WORSENED TO VOMITING, PROMPTING THE PATIENT TO GO TO THE EMERGENCY ROOM. IT IS UNCLEAR IF THE MEMBER SELF-TREATED IN ANY WAY. AT THE EMERGENCY ROOM, THE TESTS SHOWED BLOOD GLUCOSE LEVELS BETWEEN 150 AND 170. TROUBLESHOOTING WAS COMPLETED WITH THE PATIENT, AND IT WAS FOUND THAT THE PATIENT USED TEST STRIPS THAT COULD HAVE BEEN OPEN FOR OVER SIX MONTHS. ADDITIONALLY, THESE TEST STRIPS WERE STORED OUTSIDE OF THE ORIGINAL BOTTLE AND KEPT IN A ZIPPER CASE, WHICH COULD HAVE CONTRIBUTED TO TTHE INACCURATE READINGS.