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

Lot Number 2KM3E53B

Device Problems Shelf Life Exceeded (1567); High Readings (2459)

Patient Problem Hypoglycemia (1912)

Event Date 12/11/2017

Event Type  Injury  

Manufacturer Narrative

Patient and initial reporter information were not provided.

Event Description

(b)(6) customer received a blood glucose reading of 300mg/dl using a contour ts and expired strips.She was feeling hypoglycemic.Symptoms were not provided.She went to the clinic and her blood glucose was 50mg/dl.She received treatment but further information was not provided.The customer was sent new meter and strips.Product was not expected to be returned.

• Brand Name: CONTOUR TS
• 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 ; 5743149617
• MDR Report Key: 7193511
• MDR Text Key: 97339954
• Report Number: 1826988-2018-00004
• Device Sequence Number: 1
• Product Code: NBW
• 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,foreign
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 12/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2014
• Device Lot Number: 2KM3E53B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR