MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® SMARTVIEW TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS

Catalog Number	06337538001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The mother reported that the blood glucose device gave a lower than expected reading during a hyperglycemic event.The user received a blood glucose result of 117 mg/dl a little before 12:00pm on his accu-chek nano system.The user stated that he did not have an appetite and was not feeling good at this time.At approximately 12:35pm the user's parent's noticed that the customer did not "look good around the eyes" and they transported the customer to the hospital at around 1:00pm.Upon arrival at the hospital the user received a blood glucose result over 1000 mg/dl.The hospital treated the customer with insulin and other fluids via iv.The customer was also given antibiotics as he had developed thrush during his hospitalization.The customer was hospitalized for one week.

• Brand Name: ACCU-CHEK ® SMARTVIEW TEST STRIPS
• Common Device Name: BLOOD GLUCOSE MONITORING TEST STRIPS
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIABETES CARE, INC.; 9115 hague road; na; indianapolis IN 46250 1025
• Manufacturer Contact: brian frazier ; 9115 hague road; na; indianapolis, IN 46250-0457
• MDR Report Key: 20039358
• Report Number: 3011393376-2024-01731
• Device Sequence Number: 6574057
• Product Code: NBW
• UDI-Device Identifier: 00365702492103
• UDI-Public: 00365702492103
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K113137
• 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): 08/23/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 06337538001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 08/23/2024
• 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: LANTUS; NOVOLOG INSULIN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 14 YR
• Patient Sex: Male