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

Model Number	7097C
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Headache (1880); Dizziness (2194); Loss of consciousness (2418)
Date of Event	11/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As per contour blood glucose monitoring system user guide, the user must wash their hands thoroughly with warm soapy water and dry them well before testing.During the call, it was determined that the customer did not wash her hands before testing her blood glucose levels.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.
Event or Problem Description
An advocate called to report that the customer obtained blood glucose readings of 140 mg/dl while using the contour meter and 92 mg/dl with laboratory testing.Both readings were obtained at the same time.The customer was experiencing symptoms such as headache and dizziness.The customer adjusted her diet based on the meter readings by replacing carbohydrates with vegetables and felt unwell.Next day, the customer passed out.She was hospitalized and received medical attention.No further details were provided.The advocate was advised to return the tests strips for evaluation.Replacement meter and test strips were sent to the customer.
Additional Manufacturer Narrative
The customer returned the suspected contour meter for evaluation.An in-house testing was performed using the returned meter with in-house contour test strips from lot # 8cj3d02a, which gave satisfactory performance.

• Brand Name: CONTOUR
• Common Device Name: BLOOD GLUCOSE TEST STRIPS
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• MDR Report Key: 9481712
• Report Number: 1810909-2019-00567
• Device Sequence Number: 10821697
• Product Code: NBW
• UDI-Device Identifier: 10301937097505
• UDI-Public: 10301937097505
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/31/2020
• Device Model Number: 7097C
• Device Catalogue Number: 7097C
• Device Lot Number: 8CJ3D02A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Initial Date Received by Manufacturer: 11/30/2019
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 89 YR