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	Hypoglycemia (1912)
Date of Event	01/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the blood glucose monitor was unavailable for use due to several strip errors and battery/power messages.The caller reported that on (b)(6) 2023 at 3:00pm, the customer lost consciousness, due to low blood sugar.It is unknown how long the customer had been unconscious.The customer's mother in law found him passed out and called 911.The emt's arrived between 3:05pm and 3:07pm.The blood glucose result obtained by the emt's was not provided.The customer was initially taken to the hospital for an injury sustained to his thumb during the fall and then he was transported to a trauma center where he was admitted for low blood sugar, a brain bleed, and back injury.The caller reported that the customer was unable to use his meter prior to the hospitalization due to the mentioned error messages.It was reported that the customer was discharged from the hospital on (b)(6) 2023.However, at the time of the initial report on (b)(6) 2023, the customer's wife mentioned that he had gone back into the hospital after returning home last sunday.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): SANMINA-SCI CORPORATION; 13000 south memorial parkway; asku; huntsville AL 35807
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 16373781
• Report Number: 3011393376-2023-00419
• Device Sequence Number: 15180298
• Product Code: NBW
• UDI-Device Identifier: 00365702702431
• UDI-Public: 00365702702431
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 02/01/2023
• Supplement Date Received by Manufacturer: 04/14/2023; 07/22/2025
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 04/14/2023; 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male