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

Catalog Number 06908349001

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Hypoglycemia (1912)

Event Date 06/12/2018

Event Type  malfunction  

Manufacturer Narrative

It was unknown if the initial reporter sent report to the fda.

Event Description

It was reported that the patient received a blood glucose result of 228 mg/dl on the aviva system and he had symptoms of hypoglycemia.The patient's son-in-law found him unresponsive, but awake.The son-in-law treated him with honey and then called the paramedics who arrived 20 minutes later.The blood glucose result on the paramedic's meter was 4 mg/dl.It is unknown what type of treatment was given by the paramedics.The patient was taken to the hospital.The blood glucose result at the hospital was unknown.The patient was treated with antibiotics via iv and placed on oxygen at the hospital.The patient was released from the hospital on (b)(6) 2018.The test strip lot number was not provided.The remaining strips were used; therefore, no product could be requested to be returned for product evaluation.

• Brand Name: ACCU-CHEK ® AVIVA PLUS TEST STRIPS
• Type of Device: BLOOD GLUCOSE MONITORING TEST STRIPS
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIABETES CARE, INC.; 9115 hague road; na; indianapolis IN 46250 1025
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 7647768
• MDR Text Key: 112891847
• Report Number: 3011393376-2018-02781
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Catalogue Number: 06908349001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/15/2018
• Initial Date FDA Received: 06/28/2018
• 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
• Patient Age: 72 YR
• Patient Weight: 91