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

Model Number	07453701001
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Hyperglycemia (1905); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	06/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that the patient received a blood glucose result of 189 mg/dl on the accu-chek guide blood glucose monitor.This result is considered low for the patient as her normal blood glucose result is around 200 mg/dl.The patient tested on her tandem insulin pump a minute later, and the blood glucose result was 300 mg/dl.The patient experienced symptoms of nausea and weakness, so she had a friend take her to the hospital, which is around 45 minutes away from her house.The patient was treated with an unknown iv at the hospital.The blood glucose results at the hospital were not provided.The patient was admitted into the hospital until (b)(6) 2023.

• Brand Name: ACCU-CHEK ® GUIDE 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: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 17280210
• Report Number: 3011393376-2023-01535
• Device Sequence Number: 3534414
• Product Code: NBW
• UDI-Device Identifier: 00365702701977
• UDI-Public: 00365702701977
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K160944
• 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
• Report Date (Section B): 08/04/2023

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 Expiration Date: 04/18/2024
• Device Model Number: 07453701001
• Device Catalogue Number: 07453701001
• Device Lot Number: 103681
• 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: 06/29/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOVOLOG INSULIN; TANDEM INSULIN PUMP
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 73 KG