MAUDE Adverse Event Report: TAIDOC TECHNOLOGY CORPORATION / FORACARE INC. KETO-MOJO KETONE AND GLUCOSE METER; GLUCOSE DEHYDROGENASE, GLUCOSE

Model Number	TD-4279
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
I have been using the ketone meter from keto mojo (https://keto-mojo.Com/collections/all/products/td-4279-ketone-and-glucose-meter) with test strips purchased directly from keto mojo.Recent patches of test strips have been given conflicting readings that fall well outside of the expected variance / error range of the device and the test strips.

• Brand Name: KETO-MOJO KETONE AND GLUCOSE METER
• Common Device Name: GLUCOSE DEHYDROGENASE, GLUCOSE
• Manufacturer (Section D): TAIDOC TECHNOLOGY CORPORATION / FORACARE INC.
• MDR Report Key: 8164443
• Report Number: MW5082111
• Device Sequence Number: 19197247
• Product Code: LFR
• UDI-Device Identifier: 00858538007103
• UDI-Public: (01)00858538007103
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: TD-4279
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2018
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 99