MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK GUIDE; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Model Number	08053723001
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Accu-chek guide test strips stop working.I've gone through several packs where the test strips stop working 1/2 way through the package.

• Brand Name: ACCU-CHEK GUIDE
• Common Device Name: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.
• MDR Report Key: 16877015
• Report Number: MW5117273
• Device Sequence Number: 14996016
• Product Code: NBW
• UDI-Device Identifier: 00365702726109
• UDI-Public: 00365702726109
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 05/02/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/18/2023
• Device Model Number: 08053723001
• Device Catalogue Number: 08053723001
• Device Lot Number: 103295
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INSULIN PUMP.
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White