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

Catalog Number	07398794001
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	Headache (1880)
Date of Event	12/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the blood glucose monitor was unavailable for use due to power concerns.The power issue on the meter started the day prior to the event, therefore the user was unable to test.It was reported that the customer took all of her medications as normal, except her novolog insulin, prior to the event.The user reported that her novolog insulin is on a sliding scale based on her blood glucose result, and since she was unable to test, she withheld her novolog.On the morning of the incident at approximately 6:00am, the customer experienced a severe headache.At 7:00am she attempted to test on her guide meter and it still did not have power.The user's daughter called the emt's.Upon arrival, the emt's received a blood glucose result of 427 mg/dl on their professional meter.The user was treated with oxygen and 18 units of novolog.The emt's stayed with the customer for 30-45 minutes, until she recovered.The user was only treated at home and was not transported to the hospital.
Additional Manufacturer Narrative
Section g1: the manufacturer site was corrected.
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) ¿ (b)(4) to implement corrective actions was opened on january 29, 2025.Device performance and/or risk profile are not impacted.

• Brand Name: ACCU-CHEK ® GUIDE
• 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 INDIA PVT LTD.; oz-1 sipcot hi-tech sez,oragad; sriperumpudur taluk; chennai, tamil nadu AL 60210 5; IN 602105
• Manufacturer Contact: brian frazier ; 9115 hague road; na; indianapolis, IN 46250-0457
• MDR Report Key: 21069082
• Report Number: 3011393376-2025-00029
• Device Sequence Number: 8409035
• Product Code: NBW
• UDI-Device Identifier: 00365702609105
• UDI-Public: 00365702609105
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/21/2025

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 Catalogue Number: 07398794001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 02/24/2025; 07/21/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 02/25/2025; 07/21/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GABAPENTIN; GLIPIZIDE; LANTUS; METFORMIN; NOVOLOG; OZEMPIC; TIZANIDINE; XARELTO
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 89 KG