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

Model Number	08387052001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	12/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was hospitalized for hyperglycemia while using the blood glucose monitor.The patient was able to successfully test on her blood glucose monitor on (b)(6) 2022 at 5:00 p.M.The specific blood glucose result was unknown, but it was within the patient's normal range.The patient was not able to use the blood glucose monitor after this due to a power issue error message.On (b)(6) 2022 at around 9:00 a.M., the patient was experiencing symptoms of being sleepy and incoherent.The patient's husband contacted the paramedics at 10:00 a.M.And they arrived at 10:05 a.M.The patient's blood glucose level was 550 mg/dl on the paramedic's meter.The paramedics did not provide treatment and transported the patient to the hospital.It is unknown if the hospital tested the patient upon arrival.The type of treatment provided to the patient at the hospital was unknown.The patient was discharged from the hospital on (b)(6) 2022.No further information was provided.
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: 16013186
• Report Number: 3011393376-2022-03725
• Device Sequence Number: 20689486
• Product Code: NBW
• UDI-Device Identifier: 00365702702431
• UDI-Public: 00365702702431
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 07/22/2025

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2022
• Supplement Date Received by Manufacturer: 02/14/2023; 07/22/2025
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 02/15/2023; 07/22/2025
• 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: HUMALOG INSULIN; LANTUS INSULIN
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 68 KG