MAUDE Adverse Event Report: LIVONGO HEALTH INC LIVONGO BLOOD GLUCOSE METER

Model Number BG300C

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 09/30/2021

Event Type  Injury  

Manufacturer Narrative

The patient reports that she had medicated herself based on the livongo meter's results and consequently needed to call ems.The amount of medication taken is unknown, and any intervention from ems is also unknown.The bg meter has not been returned to the manufacturer.Should the device be returned, a supplemental report will be filed with the results of the testing.

Event Description

The patient reported a complaint that their livongo meter was not accurate.The patient medicated herself and afterward had to called ems.It is unknown what medication the patient took or if any intervention peformed by the ems.The patient was sent a replacement blood glucose meter and test strips.

• Brand Name: LIVONGO BLOOD GLUCOSE METER
• Type of Device: BLOOD GLUCOSE METER
• Manufacturer (Section D): LIVONGO HEALTH INC; 150 w. evelyn ave; suite 150; mountain view CA 94041
• Manufacturer (Section G): LIVONGO HEALTH INC; 150 w. evelyn ave; suite 150; mountain view CA 94041
• Manufacturer Contact: michael chibbaro ; 150 w. evelyn ave; suite 150; mountain view, CA 94041
• MDR Report Key: 12701098
• MDR Text Key: 278548773
• Report Number: 3011196194-2021-00017
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K133584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BG300C
• Device Catalogue Number: FG00408
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR