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

Lot Number 4627822

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2020

Event Type  malfunction  

Event Description

Patient states test strips are providing inaccurate testing results.Patient tested several times in a row using the same lot of test strips and received results that varied by 100mg/dl or more from test strip to test strip.

• Brand Name: ONE TOUCH ULTRA STRIPS
• Type of Device: GLUCOSE OXIDASE, GLUCOSE
• Manufacturer (Section D): LIFESCAN
• MDR Report Key: 10777827
• MDR Text Key: 214541817
• Report Number: MW5097612
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 53885024510
• UDI-Public: 53885024510
• 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: 10/27/2020

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: No Information
• Device Lot Number: 4627822
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 78 YR