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

Catalog Number 06870287001

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2017

Event Type  malfunction  

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

Caller states that her aviva model 455 was reading in mmol/l, but a month ago it switched and began reading in mg/dl.The aviva model 455 is a u.S meter that is configured to read in mg/dl.This blood glucose device should not have been distributed in canada.No actions taken based on device results.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: 6646196
• MDR Text Key: 77719238
• Report Number: 3011393376-2017-03518
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

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: 06/05/2017
• Initial Date FDA Received: 06/16/2017
• Supplement Dates Manufacturer Received: 11/13/2017
• Supplement Dates FDA Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 70