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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the patient received the following results within 15 minutes: 78 mg/dl, 230 mg/dl and 456 mg/dl.

• 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
• MDR Report Key: 10319632
• Report Number: 3011393376-2020-02645
• Device Sequence Number: 19577936
• Product Code: NBW
• UDI-Device Identifier: 00365702492103
• UDI-Public: 00365702492103
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K113137
• 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): 10/07/2020

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: 06/30/2021
• Device Catalogue Number: 06337538001
• Device Lot Number: 478662
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 10/07/2020
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 252