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

Lot Number 9EPBF02A

Device Problem High Readings (2459)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 12/03/2019

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 age and weight were not provided.The model # was not provided.

Event Description

The customer from (b)(6) reported that at 8:23 p.M., he obtained a blood glucose reading of 27.3 mmol/l while using the contour next one meter.At 8:24 p.M., he performed comparison testing with a non-ascensia meter and obtained a reading of 11.4 mmol/l.Based on the high reading, the customer administered insulin.The next day, at 1:52 a.M., he obtained a reading of 8.2 mmol/l and was feeling unwell, however, he did not require any medical attention.There was no allegation of an adverse event.The customer was advised to return the product for evaluation.A replacement meter kit was sent to the customer.

Manufacturer Narrative

The customer returned the suspected contour next one meter for evaluation.The test strips were not returned.Since the test strip lot number provided by the customer does not exist, a similar contour next test strip from lot # 9epef02a was used for in-house testing.During in-house testing, the returned meter was tested with the in-house test strips, which gave satisfactory performance.

• Brand Name: CONTOUR NEXT
• 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: 9542116
• MDR Text Key: 174704999
• Report Number: 1810909-2020-00002
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K160682
• 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: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2021
• Device Lot Number: 9EPBF02A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1