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

Catalog Number 05075645005

Device Problem Communication or Transmission Problem (2896)

Patient Problem Diabetic Ketoacidosis (2364)

Event Date 05/27/2019

Event Type  Injury  

Event Description

It was reported that the patient was hospitalized for diabetic ketoacidosis while using the blood glucose monitor.The blood glucose monitor and the infusion device were not communicating, but the blood glucose monitor would still allow the patient to access bolus advice and would display "manual pump".The patient was accessing the bolus advice and confirming bolus amounts, but would not receive the bolus amounts through the infusion device.It was alleged that the high blood glucose was related to the communication issue and not related to the infusion device delivery.The patient's blood glucose result was in the "400's mg/dl range" at an unknown time on her aviva combo meter prior to arriving at the hospital.The patient's blood glucose result was 400 mg/dl on the hospital's meter when she arrived.It is unknown what type of treatment the patient received at the hospital.The patient was hospitalized for approximately 2 days.

• Brand Name: ACCU-CHEK ® AVIVA COMBO
• 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: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 8695143
• MDR Text Key: 147854846
• Report Number: 3011393376-2019-02118
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111353
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

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
• Device Catalogue Number: 05075645005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/29/2019
• Initial Date FDA Received: 06/13/2019
• Supplement Dates Manufacturer Received: 09/10/2019
• Supplement Dates FDA Received: 09/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: UNKNOWN INSULIN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR