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

Device Problem Power Problem (3010)

Patient Problem Hypoglycemia (1912)

Event Date 07/11/2022

Event Type  Injury  

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

The patient reported that the blood glucose meter turned off unexpectedly and did not turn on again.She stated three days ago she had hypoglycemia and the meter would not turn on.She could not measure her blood glucose value because the meter was unavailable for use.She was not able to self-treat anymore and needed help from a second person.She was given coca-cola and felt better.

• Brand Name: ACCU-CHEK ® GUIDE
• 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; 13000 south memorial parkway; na; huntsville AL 35807
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 15140587
• MDR Text Key: 296998734
• Report Number: 3011393376-2022-02284
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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,Followup
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/14/2022
• Initial Date FDA Received: 08/01/2022
• Supplement Dates Manufacturer Received: 09/06/2022
• Supplement Dates FDA Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female