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

Model Number	08387052001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the blood glucose monitor was unavailable for use due to a strip error.On (b)(6) 2022 the patient attempted to test his blood glucose and received an e-11 message.On (b)(6) 2022 the customer experienced elevated blood glucose levels of feeling light headed and dizzy.The customer was unable to obtain a reading on their guide meter, due to an e11 message.The customer took his normal dosage of medication and at 2:00pm went to the hospital.Upon arrival at the hospital, the customer received a blood glucose result of 277 mg/dl.The customer was treated for hyperglycemia, however the type of treatment received was not provided.It is unknown how long the customer was hospitalized.
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: 15536548
• Report Number: 3011393376-2022-02900
• Device Sequence Number: 6037137
• Product Code: NBW
• UDI-Device Identifier: 00365702702431
• UDI-Public: 00365702702431
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Follow-Up
• Initial Date Received by Manufacturer: 09/12/2022
• Supplement Date Received by Manufacturer: 10/10/2022; 07/22/2025
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 10/14/2022; 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: UNKNOWN DIABETES MEDICATION
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male