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

Model Number	07453710001
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the patient received the following results within 15 minutes: hi mg/dl (which on the system indicates a result in excess of 600 mg/dl) and 145 mg/dl.

• 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: 12496439
• Report Number: 3011393376-2021-02910
• Device Sequence Number: 3695194
• Product Code: NBW
• UDI-Device Identifier: 00365702710108
• UDI-Public: 00365702710108
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/24/2021

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 Expiration Date: 09/22/2022
• Device Model Number: 07453710001
• Device Catalogue Number: 07453710001
• Device Lot Number: 102480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 09/24/2021
• Patient Sequence Number: 1
• Patient Age: 59 YR