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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

It was reported the patient received an e-57 (= electronic error) message on her aviva combo meter.The patient inserted new batteries, but the meter did not work anymore.Therefore, the patient had to inject insulin directly with the pump without a bolus calculation.After a while, the patient was suffering from ketoacidosis and called the ambulance.The patient was administered insulin in the ambulance in front of her house.After 45 minutes, as the patient was not reacting to the given insulin, she was admitted to the hospital for further treatment.Patient was hospitalized for one week.At the hospital, the nurse inserted new batteries in the meter and the meter has been working again ever since.Therefore, the patient does not want to return the meter for investigation.

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.Patient is not willing to return the device.

• 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: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 15319034
• MDR Text Key: 298863549
• Report Number: 3011393376-2022-02570
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• 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: 08/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN INSULIN
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Female