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

Model Number 7080G

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/12/2017

Event Type  malfunction  

Manufacturer Narrative

The patient was the initial reporter, so personal information was not entered.The customer strips were returned for evaluation.Although it could not be determined if the bottle cap was already open when the customer got them, the strips gave e11 on all samples using control, which is an indication the strips were exposed to moisture.

Event Description

The customer stated the bottle of contour test strips was not closed tightly when he first opened it.He used the strips anyway and suspected he was getting higher readings than normal.There was no adverse event alleged.The customer returned the strips for evaluation as exposed strips can cause high results.New strips were sent to him.

• Brand Name: CONTOUR
• Type of Device: BLOOD GLUCOSE TEST STRIPS
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC; 430 s beiger st; mishawaka IN 46544
• Manufacturer (Section G): ASCENSIA DIABETES CARE US INC; 430 s beiger st; mishawaka IN 46544
• Manufacturer Contact: jeri messmore ; 430 s beiger st; mishawaka, IN 46544
• MDR Report Key: 6836729
• MDR Text Key: 84352492
• Report Number: 1826988-2017-00289
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 10301937080507
• UDI-Public: 10301937080507
• Combination Product (y/n): N
• PMA/PMN Number: K062058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 08/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Model Number: 7080G
• Device Catalogue Number: 7080G
• Device Lot Number: 6JJ3B04A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1