MAUDE Adverse Event Report: LIFESCAN, INC. ONE TOUCH ULTRA TEST STRIPS; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Lot Number 4580171

Device Problem Imprecision (1307)

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

Event Date 08/22/2020

Event Type  malfunction  

Event Description

One touch ultra glucose strips lot 4580171 gives wildly inaccurate readings at high glucose levels my dexcom g6 and a different lot both read 174-177, while 3 checks from the problem lot read from 222- 258 i contacted lifescan customer service, but they just sent me a form email back.Fda safety report id# (b)(4).

• Brand Name: ONE TOUCH ULTRA TEST STRIPS
• Type of Device: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): LIFESCAN, INC.
• MDR Report Key: 10465309
• MDR Text Key: 204915394
• Report Number: MW5096315
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/26/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2021
• Device Lot Number: 4580171
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 98