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

Model Number	05423066001
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	04/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the meter was unavailable for use due to an error message that the battery has to be changed.The customer experienced a high blood glucose value of 600 mg/dl.The patient felt light headed and general malaise between 11:00 am and 12:00 pm.She stated that she would have normally taken 1000 mg of metformin at this time but she did not treat herself.Her son drover her to the hospital and they arrived at 1:30, they put her on an ekg and she was diagnosed with an aneurysm and admitted.She was scheduled for surgery at 2:30 pm.During the preparation for surgery, she was given a blood sugar test on the hospital meter and got a result of 600 mg/dl.They decided to postpone surgery until blood sugar was normal.
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 ® NANO
• 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 CORPORATION; 13000 south memorial parkway; na; huntsville AL 35803
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 9327958
• Report Number: 3011393376-2019-04155
• Device Sequence Number: 16242830
• Product Code: NBW
• UDI-Device Identifier: 00365702637108
• UDI-Public: 00365702637108
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K113137
• 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: 05423066001
• Device Catalogue Number: 05423066001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 01/19/2020; 07/22/2025
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 01/30/2020; 07/23/2025
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: METFORMIN 1000 MG; METFORMIN 1000 MG
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 82 KG