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

Catalog Number 03532275002

Device Problem Measurement System Incompatibility (2982)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Customer states that his aviva model 525 reads in mmol/l, rather than mg/dl.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: 6660135
• MDR Text Key: 78179534
• Report Number: 3011393376-2017-03671
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 03532275002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR