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

Catalog Number 06870287001

Device Problem Electrical Shorting (2926)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2019

Event Type  malfunction  

Event Description

The customer alleged that the meter produced smoke from the test strip slot of the device.No adverse event was reported.The blood glucose monitor was requested to be returned for product evaluation.

• Brand Name: ACCU-CHEK ® AVIVA
• 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: 8373450
• MDR Text Key: 137245681
• Report Number: 3011393376-2019-00769
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043474
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

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: Lay User/Patient
• Device Catalogue Number: 06870287001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 02/27/2019
• Supplement Dates Manufacturer Received: 06/25/2019
• Supplement Dates FDA Received: 07/02/2019
• 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
• Patient Age: 72 YR
• Patient Weight: 75