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

Device Problem Complete Loss of Power (4015)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 01/20/2021

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

It was reported that the blood glucose monitor was unavailable for use due to power concerns.The mother reported that approximately a month and a half ago the customer experienced a hypoglycemic event.On the day of the event the patient attempted to test her blood glucose and the meter would not power on.The patient was experiencing symptoms of hypoglycemia at this time.The mother instructed the customer to go to the pharmacy to take her blood glucose, before administering her insulin dosage.The customer refused to go to the pharmacy and injected 10 units of insulin.At an unknown time the patient went into a coma and was rushed to the hospital.The blood glucose results obtained at the hospital were not provided.At the hospital the customer was treated with intravenous solutions and another unknown medication.The patient was discharged from the hospital the following day.A second event occurred, but the date was unknown.The mother reported that the caller was having difficulty breathing.The customer attempted to test their blood glucose and the meter would not power on.The customer was rushed to the hospital.Upon arrival at the hospital the customer received a blood glucose result of hi mg/dl.The hospital treated the patient with unknown medication and the customer was discharged after 3 hours.

• 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
• MDR Report Key: 11435519
• MDR Text Key: 238350668
• Report Number: 3011393376-2021-00752
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN INSULIN; UNKNOWN INSULIN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 13 YR
• Patient Weight: 50