MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. CONTOUR PLUS; BLOOD GLUCOSE TEST STRIPS

Device Problem Missing Information (4053)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/24/2020

Event Type  malfunction  

Manufacturer Narrative

The patient/family was the initial reporter, so personal information was not entered.No information was captured as the customer's weight was not provided.Since the product information was not available, the model #, lot # and expiration date was left blank, and the device manufacture date could not be determined.

Event Description

An advocate from (b)(6) alleged that there was no labeling information (lot #, expiration date and control ranges) on the bottle of the contour plus test strips.There was no allegation of an adverse event.The advocate was advised to return the device for evaluation.Replacement meter kit and test strips were sent to the customer.

Manufacturer Narrative

The customer did not return the device for evaluation.Since the lot # of the suspected test strips was not available and the device was not returned, no further investigation could be performed.

• Brand Name: CONTOUR PLUS
• Type of Device: BLOOD GLUCOSE TEST STRIPS
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• MDR Report Key: 11386212
• MDR Text Key: 239764716
• Report Number: 1810909-2021-00115
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K121190
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR