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

Catalog Number	08387052001
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	04/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, the customer experienced issues with high blood glucose levels of 500 mg/dl and hyperglycemia symptoms that led to hospitalization.Prior to the incident, the customer had attempted to use her accu-chek guide me meter in the morning, but an e-9 (= power problems) was displayed.The customer did not take insulin because she could not get a reading on her meter.At 1:00pm, the customer was driven to her doctor by her daughter, and then was admitted to the hospital by 2:00pm with a blood glucose reading near 500 mg/dl.The patient was treated with an iv, 20-unit humalog injection, tylenol, and a novocain patch, she briefly lost consciousness.She was released at 6:05pm with a reading of 130 mg/dl, her meter showed 289 mg/dl at 11:00pm.She still feels lightheaded, shaky, and sleepy.

• 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; 77, 3rd main street; na; kunshan ; CH
• Manufacturer Contact: natalie catton ; 9115 hague road; na; indianapolis, IN 46250-0457
• MDR Report Key: 21926360
• Report Number: 3011393376-2025-00580
• Device Sequence Number: 8651173
• Product Code: NBW
• UDI-Device Identifier: 00365702702431
• UDI-Public: 00365702702431
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 07/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 08387052001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HUMALOG INSULIN
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 110 KG