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

Model Number 08256292001

Device Problem Insufficient Information (3190)

Patient Problem Hypoglycemia (1912)

Event Date 05/09/2022

Event Type  Injury  

Event Description

It was reported that the blood glucose monitor was unavailable for use due to a strip error.On the day of the event the customer attempted to test his blood glucose throughout the day and continued to receive e-3 strip errors.Around 9:00pm the customer took his 38 units of lantus and 10 units of novolog, which is his normal dosage.At 9:30pm the customer began to experience low blood glucose symptoms of feeling weak and having trouble walking and using his hands.The customer attempted to test his blood glucose at this time and received an e-3 message.The customer made himself a sandwich, in an attempt to self-treat, however when walking into the living room to eat he collapsed and lost consciousness.This wife found him on the living room floor and called 911.The emt's arrived around 10:00pm and received a blood glucose result of 40 mg/dl.He advised that the emt's treated him for low blood glucose, however he does not know what type of treatment was provided.He advised he began to recover within 30-45 minutes after the treatment and was not taken to the hospital.The emt's tested his blood glucose before they left and he received a result of 70 mg/dl.

• Brand Name: ACCU-CHEK ® GUIDE TEST STRIPS
• Type of Device: BLOOD GLUCOSE MONITORING TEST STRIPS
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIABETES CARE, INC.; 9115 hague road; na; indianapolis IN 46250 1025
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 14487192
• MDR Text Key: 292483020
• Report Number: 3011393376-2022-01549
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00365702719101
• UDI-Public: 00365702719101
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/19/2023
• Device Model Number: 08256292001
• Device Catalogue Number: 08256292001
• Device Lot Number: 103074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2022
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Treatment: LANTUS; NOVOLOG INSULIN
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 83 KG