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

Model Number	06337546001
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	02/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the patient received the following results within 15 minutes: 172 mg/dl, 182 mg/dl and 90 mg/dl using the nano meter.The patient felt like having low blood sugars and was able to self-treat by taking fast acting glucose supplement.

• 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: 11387971
• Report Number: 3011393376-2021-00633
• Device Sequence Number: 3545780
• Product Code: NBW
• UDI-Device Identifier: 00365702493100
• UDI-Public: 00365702493100
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 05/21/2021

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: Other
• Device Expiration Date: 02/28/2022
• Device Model Number: 06337546001
• Device Catalogue Number: 06337546001
• Device Lot Number: 479292
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 05/21/2021
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 66