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 Codes	Hypoglycemia (1912); Dizziness (2194)
Date of Event	07/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was admitted to hospital with a low blood glucose level because the blood glucose meter could not be used.One day before the incident, the patient had measured a blood glucose level of 160 mg/dl with his meter.The next day, he woke up at 8:00 am and felt dizzy.He tried to use the meter, but the meter turned off immediately after he turned it on.He administered himself 10 units of levemir insulin by pen and took 6.25 mg of alogliptin independently.As he continued to feel dizzy, he called the paramedics at 9:00 am.Paramedics arrived 10 minutes later and drove him to the emergency room.The blood glucose readings or how the paramedics treated him are not known.At the hospital, the patient was given food and drink to treat his low blood glucose levels.The patient was discharged from the hospital in the evening of the same day.Blood glucose readings measured at the hospital are not known.
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: 12263505
• Report Number: 3011393376-2021-02333
• Device Sequence Number: 4689804
• Product Code: NBW
• UDI-Device Identifier: 00365702702431
• UDI-Public: 00365702702431
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 08/09/2021; 07/22/2025
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 08/10/2021; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: ALOGLIPTIN 6.25 MG; LEVEMIR INSULIN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 73 KG