MAUDE Adverse Event Report: TAIDOC TECHNOLOGY CORPORATION KETO-MOJO; B-KETONE & BLOOD GLUCOSE MONITORING SYSTEM

Model Number TD-4279

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

We received the medwatch notification from fda on 1/10 and confirmed that neither taidoc nor (b)(6).Had received any complaints related to this medwatch report (mw5082111).Besides, the reporter did not provide details either about the device, such as the test strip lot number or how the reading fell outside so-called error range, for us to take further actions to perform a quality check and provide feedback, or the personal contact information for the distributor to obtain more information or provide assistance.We selected five lots of test strip of the keto-mojo system that were released between june 2017 and december 2018 to test their precision and accuracy and see if they all meet the requirements.Preliminary analysis of complaints, report no.(b)(4), for test results.[(b)(4), mw5082111.Pdf].

Event Description

The patient stated that he/she purchased the keto-mojo meter and test strips directly from (b)(6) and some patches of the test strips had been given conflicting readings that fell outside of the expected variance / error range of the system.

• Brand Name: KETO-MOJO
• Type of Device: B-KETONE & BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): TAIDOC TECHNOLOGY CORPORATION; b1-7f, no. 127, wugong 2nd rd.; wugu dist.; new taipei city, 24888 ; TW 24888
• Manufacturer Contact: anne kuo ; b1-7f, no.127, wugong 2nd rd.; wugu dist.; new taipei city, 24888 ; TW 24888
• MDR Report Key: 8863223
• MDR Text Key: 216607893
• Report Number: 3004145393-2019-00001
• Device Sequence Number: 1
• Product Code: JIN
• Combination Product (y/n): N
• PMA/PMN Number: K161738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: TD-4279
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 08/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 50 YR