MAUDE Adverse Event Report: UNKNOWN OT ULTRA TEST STRIPS; GLUCOSE OXIDASE, GLUCOSE

Lot Number 3301545

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The enclosed document is our monthly report for complaints received by lifescan, inc., regarding counterfeit lifescan device(s) (glucose test strips) for the month of (b)(6) 2013.The spreadsheet lists complaints by strip lot number and contains line-item listings for each complaint by product issue (pi)#, alert date, product name, lot#, adverse event or malfunction (brief description included), and country where the complaint originated (usa or non-usa).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: OT ULTRA TEST STRIPS
• Type of Device: GLUCOSE OXIDASE, GLUCOSE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17524445
• MDR Text Key: 321432476
• Report Number: MW5131392
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2013

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?: No
• Device Lot Number: 3301545
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1