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

Catalog Number 06870244001

Device Problem Power Problem (3010)

Patient Problem Hyperglycemia (1905)

Event Date 11/04/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced hyperglycemia while using the blood glucose monitor.The blood glucose monitor was not working as normal and only powered on after many attempts of removing and reinserting the battery.The patient was not able to use the device as frequently.The last use of the blood glucose monitor was 1 day prior to the event.The patient experience symptoms of vomiting, not eating, and the flu.The patient's mother was not giving the patient medication because he was not eating.The patient was transported to the hospital where the blood glucose level was 520 mg/dl.The patient received unknown treatment via iv at the hospital.The patient was hospitalized for 4 hours.The patient's blood glucose level was tested again and it was 411 mg/dl.

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.

• Brand Name: ACCU-CHEK ® PERFORMA
• 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: 15795777
• MDR Text Key: 303627891
• Report Number: 3011393376-2022-03354
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 06870244001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 8 YR
• Patient Sex: Male
• Patient Weight: 25 KG