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

Model Number 06337546001

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Hypoglycemia (1912); Sweating (2444)

Event Date 12/09/2020

Event Type  malfunction  

Event Description

It was reported the patient received the following results within 15 minutes: 119 mg/dl and 55 mg/dl.

• Brand Name: ACCU-CHEK SMARTVIEW TEST STRIPS
• Type of Device: BLOOD GLUCOSE MONITORING TEST STRIPS
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11055017
• MDR Text Key: 223056640
• Report Number: 3011393376-2020-04584
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00365702493100
• UDI-Public: 00365702493100
• Combination Product (y/n): N
• PMA/PMN Number: K113137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2021
• Device Model Number: 06337546001
• Device Catalogue Number: 06337546001
• Device Lot Number: 479034
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 03/10/2021
• Supplement Dates FDA Received: 03/29/2021
• Patient Sequence Number: 1
• Treatment: NOVOLIN N INSULIN; NOVOLIN N INSULIN
• Patient Age: 76 YR
• Patient Weight: 120