MAUDE Adverse Event Report: ROCHE ACCU-CHEK AVIVA PLUS TEST STRIPS; BLOOD GLUCOSE MONITORING TEST STRIPS

Catalog Number 65702-0407-10

Device Problem Defective Device (2588)

Patient Problem No Information (3190)

Event Date 07/07/2014

Event Type  malfunction  

Event Description

Box label says it contains "1 black code key." there was not a code key in the box.The patient's wife brought it back to the pharmacy as defective.When the manufacturer was contacted, we were told that it is no longer needed.Diagnosis or reason for use: diabetes.Frequency: bid.

• Brand Name: ACCU-CHEK AVIVA PLUS TEST STRIPS
• Type of Device: BLOOD GLUCOSE MONITORING TEST STRIPS
• Manufacturer (Section D): ROCHE
• MDR Report Key: 3949846
• MDR Text Key: 4603827
• Report Number: MW5037325
• Device Sequence Number: 1
• Product Code: LFR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: 65702-0407-10
• Device Lot Number: 492219
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 71 YR