MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® GUIDE; BLOOD GLUCOSE MONITORING TEST STRIPS

Catalog Number	07453710001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	Hypoglycemia (1912); Shaking/Tremors (2515)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The caller reported that the blood glucose device gave a higher-than-expected reading during a hypoglycemic event.The user was experiencing low blood glucose symptoms of a headache, dizziness, and feeling faint.The user tested on her guide system and received a blood glucose result of 93 mg/dl, which she felt was erroneously high.The user was unable to self-treat and her husband called the emt's.The blood glucose result and treatment provided by the emt's was not provided.The user was transported to the hospital.The blood glucose result obtained at the hospital was not provided.The user was treated for low blood glucose at the hospital, however the type of treatment given was not provided.It is unknown how long the customer was hospitalized.The user declined to provide any further details.

• Brand Name: ACCU-CHEK ® GUIDE
• Common Device Name: BLOOD GLUCOSE MONITORING TEST STRIPS
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIABETES CARE, INC.; 9115 hague road; na; indianapolis IN
• Manufacturer Contact: natalie catton ; 9115 hague road; na; indianapolis, IN 46250-0457
• MDR Report Key: 21926454
• Report Number: 3011393376-2025-00581
• Device Sequence Number: 18397502
• Product Code: LFR
• UDI-Device Identifier: 00365702710108
• UDI-Public: 00365702710108
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K160944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2025

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: 06/10/2026
• Device Catalogue Number: 07453710001
• Device Lot Number: 105285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female