MAUDE Adverse Event Report: LIFESCAN ONE TOUCH ULTRA STRIP BLUE; GLUCOSE OXIDASE, GLUCOSE

Lot Number 4133792

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 05/04/2018

Event Type  malfunction  

Event Description

Pt stated that she was getting readings for blood glucose that were 100 points higher than usual, when compared to results using a different lot of test strips.Diagnosis or reason for use: diabetes.

• Brand Name: ONE TOUCH ULTRA STRIP BLUE
• Type of Device: GLUCOSE OXIDASE, GLUCOSE
• Manufacturer (Section D): LIFESCAN
• MDR Report Key: 7515297
• MDR Text Key: 108393855
• Report Number: MW5077213
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 53885024510
• UDI-Public: 53885024510
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2018
• Device Lot Number: 4133792
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR