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

Catalog Number 07819382022

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

Patient Problem Hypoglycemia (1912)

Event Date 02/17/2024

Event Type  Injury  

Event Description

It was reported that the blood glucose readings provided by the patient's accu-chek instant meter were inaccurate.No exact values reported.But the patient experienced symptoms of hyperglycemia and changed the medication due to the blood glucose results.Afterwards, the patient experienced symptoms of hypoglycemia.The caregiver gave the patient something to eat and brought him to the hospital.There is no information available regarding the treatment or the duration of the hospitalization.

Manufacturer Narrative

The event occurred outside of the united states while this product is not sold in the united states, it is like or similar to a product marketed in the united states.

Event Description

Additional information provided by the patient: the patient had a blood glucose value of 100 mg/dl, while experiencing hyperglycemia symptoms.Furthermore, the user's blood glucose meter gave a test result of 17 mg/dl and the patient was treated with some food.The time frame between the test results is unknown.

• Brand Name: ACCU-CHEK ® INSTANT 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 GMBH; sandhoferstrasse 116; na; mannheim 68305 ; GM 68305
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 18978085
• MDR Text Key: 338590978
• Report Number: 3011393376-2024-00715
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 07819382022
• Device Lot Number: 302634
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2023
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Male