MAUDE Adverse Event Report: LIFESCAN SCOTLAND LTD. ONETOUCH; GLUCOSE OXIDASE, GLUCOSE

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

Patient Problem Insufficient Information (4580)

Event Date 04/03/2023

Event Type  malfunction  

Event Description

The patient had previously used a onetouch device and the patient reported that the product was not accurate.Pae reported by patience s at hcp, (b)(6), aprn's office.Patience did consent to follow up; (b)(6).

• Brand Name: ONETOUCH
• Type of Device: GLUCOSE OXIDASE, GLUCOSE
• Manufacturer (Section D): LIFESCAN SCOTLAND LTD.
• MDR Report Key: 16690535
• MDR Text Key: 312894223
• Report Number: MW5116394
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/03/2023

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2023
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male