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

Catalog Number 06454011023

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2018

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

Customer allegedly received the following results, with two different meters, within 10 minutes: 216 mg/dl (active) and 98 mg/dl (performa).No adverse event reported.Return of the suspect device was requested for evaluation.

Manufacturer Narrative

Device received in a condition which made analysis impossible.Unable to test because test strips had expired before they were received for investigation.

• Brand Name: ACCU-CHEK ® PERFORMA 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: 7646310
• MDR Text Key: 112725507
• Report Number: 3011393376-2018-02709
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 12/11/2018

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: Lay User/Patient
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 06454011023
• Device Lot Number: 476059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/12/2018
• Initial Date FDA Received: 06/28/2018
• Supplement Dates Manufacturer Received: 11/27/2018
• Supplement Dates FDA Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/30/2017
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 45