MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. CONTOUR NEXT; QUALITY CONTROL MATERIAL

Model Number 7314

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2014

Event Type  malfunction  

Manufacturer Narrative

The customer's control solution was tested in qa with inhouse strips and gave high out of spec readings that were not marked as control tests.Satisfactory performance using retention reagent and qa control.

Event Description

The customer received a high out of range control result of 271mg/dl on the contour next usb.The meter did not automatically mark it as a control test, which will be displayed as a blood result when accessing the meter¿s memory.No adverse event was alleged.Control solution is to be returned for evaluation.New strips, meter and control were sent to the customer.

Manufacturer Narrative

Remedial action and correction/removal reporting number, this information was not provided in the initial report.

• Brand Name: CONTOUR NEXT
• Type of Device: QUALITY CONTROL MATERIAL
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 430 s. beiger st.; mishawaka IN 46544
• Manufacturer (Section G): BAYER HEALTHCARE LLC; 430 s. beiger st.; mishawaka IN 46544
• Manufacturer Contact: jeri messmore ; 430 s. beiger st.; mishawaka, IN 46544 ; 5742567719
• MDR Report Key: 4251719
• MDR Text Key: 12700017
• Report Number: 1826988-2014-00414
• Device Sequence Number: 1
• Product Code: JJX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2014

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: 02/28/2015
• Device Model Number: 7314
• Device Lot Number: 2764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/19/2014
• Initial Date FDA Received: 11/14/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/17/2014; 04/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2482-2015
• Patient Sequence Number: 1