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

Catalog Number	08387052001
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the batteries exploded within the meter.The battery door cannot be opened because it is burnt and the batteries can be seen from the edges of the door.

• Brand Name: ACCU-CHEK ® GUIDE ME
• Common Device Name: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ALTEK MEDICAL (KUNSHAN) LTD.; na77, 3rd main street; jiangsu province; kunshan ; CH
• Manufacturer Contact: natalie catton ; 9115 hague road; na; indianapolis, IN 46250-0457
• MDR Report Key: 24813003
• Report Number: 3011393376-2026-00219
• Device Sequence Number: 9686871
• Product Code: NBW
• UDI-Device Identifier: 00365702702431
• UDI-Public: 00365702702431
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K181131
• 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): 05/06/2026

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 Catalogue Number: 08387052001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/10/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 51 YR
• Patient Sex: Male