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

Catalog Number	07398794001
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the blood glucose monitor was reading in the incorrect unit of measure.

• 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 CORPORATION; 13000 south memorial parkway; huntsville AL 35807
• Manufacturer Contact: brian frazier ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 19995182
• Report Number: 3011393376-2024-01679
• Device Sequence Number: 8363266
• Product Code: NBW
• UDI-Device Identifier: 00365702609105
• UDI-Public: 00365702609105
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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
• Report Date (Section B): 10/01/2024

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 Catalogue Number: 07398794001
• 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: 07/16/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: HUMALOG, 14 UNITS DURING THE DAY AS NEEDED; LANTUS, 96 UNITS IN THE EVENING AS NEEDED
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 57 KG