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

Model Number	08387052001
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	07/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a low blood glucose level because the blood glucose meter could not be used.On the morning of the incident day, the patient had measured a blood glucose level of 134 mg/dl with her meter.Around 4:15-4:20 pm, she felt that her blood glucose was too low.She felt dizzy and tried to check her blood glucose, but the meter would not turn on.She asked her daughter to reset the meter for her, and her daughter tested her blood glucose with the meter, which was 74 mg/dl at 4:23 pm.Her daughter gave her some apple juice and a sandwich to take herself.However, she believes that she could not have gotten the juice or food due to her diabetic condition and could not reset the meter on her own or test her blood glucose on her own without assistance.She stated that she felt better half an hour after the treatment and did not test her blood glucose again until around 9.30pm the night before she went to bed.The value was in her normal range of about 120 mg/dl.
Additional Manufacturer Narrative
This supplemental mdr is being submitted as a part of a retrospective review and remediation effort based on errors that occurred in the submission of mdrs for incorrect manufacturer name and/or address.A non-conformance report (ncr) ¿ 16847 to implement corrective actions was opened on january 29, 2025.Device performance and/or risk profile are not impacted.

• 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 LIMITED.; 3rd main street; 2f, building no. 1; jiangsu AL 21530 1; CH 215301
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 12365017
• Report Number: 3011393376-2021-02605
• Device Sequence Number: 3821253
• Product Code: NBW
• UDI-Device Identifier: 00365702702431
• UDI-Public: 00365702702431
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K181131
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2025

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 Model Number: 08387052001
• Device Catalogue Number: 08387052001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 09/09/2021; 07/22/2025
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 09/10/2021; 07/23/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GLIMEPIRIDE 4MG; METFORMIN 1000 MG; GLIMEPIRIDE 4MG; METFORMIN 1000 MG
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 119 KG