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

Model Number	05423066001
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the nano meter was reading in the incorrect unit of measure.The caller reported that the blood glucose device is labeled to read in mg/dl, but changed to mmol/l.The caller reported the customer received a result of 11.5 mmol/l.
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: 11119015
• Report Number: 3011393376-2021-00043
• Device Sequence Number: 11775061
• Product Code: NBW
• UDI-Device Identifier: 00365702637108
• UDI-Public: 00365702637108
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 01/28/2021
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 01/02/2021
• Supplement Date Received by Manufacturer: 03/12/2021; 07/22/2025
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 04/06/2021; 07/31/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN INSULIN; UNKNOWN INSULIN
• Patient Sex: Male