MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® AVIVA; BLOOD GLUCOSE MONITORING DEVICE

Catalog Number 08340331001

Device Problem Insufficient Information (3190)

Patient Problem Hypoglycemia (1912)

Event Date 07/14/2023

Event Type  Injury  

Event Description

It was reported that the blood glucose monitor was unavailable for use due to an error message.On the morning of (b)(6) 2023 the customer received a blood glucose result of 153 mg/dl at 7:30am.This was a normal blood glucose reading for the customer and he administered his normal 20 units of lantus.Sometime between the timeframe of 12:30 pm and 5:15 pm the customer lose coconsciousness and had a seizure due to low blood sugar.The customer was home alone when he lost consciousness and could not recall the exact time.The customer attempted to test his blood sugar prior to losing consciousness and received an e6 error message on the device.The customer's wife arrived home at 5:15pm and discovered the customer conscious in the bathroom, she attempted to test his blood glucose and again received an error message of e6.The wife then treated the customer with orange juice and peanut butter.At 5:30pm the wife attempted to test the customer's blood glucose again, and finally received a result of 109 mg/dl.The wife drove the customer to the hospital.They arrived at the hospital at 6:15p and the hospital tested the customer's blood glucose and received a result of 240 mg/dl.The hospital performed a series of tests and ran an ekg.No treatment was provided for diabetes.The customer was not admitted into the hospital and went home 2 hours later.

Manufacturer Narrative

Correction d4: catalog no and unique identifier were updated based on the returned product.

• Brand Name: ACCU-CHEK ® AVIVA
• Type of Device: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): SANMINA-SCI CORPORATION; rathealy road; na; fermoy 00000 ; EI 00000
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 17410298
• MDR Text Key: 319918699
• Report Number: 3011393376-2023-01725
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00365702702394
• UDI-Public: 00365702702394
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043474
• 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: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 08340331001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Treatment: LANTUS
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 83 KG