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 Code	Hyperglycemia (1905)
Date of Event	03/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the patient received the following results within 15 minutes: 104 mg/dl and 460 mg/dl.The patient self-treated with insulin due to elevated blood glucose result.

• 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
• MDR Report Key: 11685189
• Report Number: 3011393376-2021-01240
• Device Sequence Number: 11487903
• Product Code: NBW
• UDI-Device Identifier: 00365702701977
• UDI-Public: 00365702701977
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 04/19/2021

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: 07453701001
• Device Catalogue Number: 07453701001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 04/19/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STERIODS; UNKNOWN INSULIN
• Patient Age: 60 YR
• Patient Weight: 76