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

Model Number	7098C
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Sweating (2444); Confusion/ Disorientation (2553)
Date of Event	10/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that at 6:42 a.M., he obtained a blood glucose reading of 90 mg/dl on his contour meter.The customer was experiencing symptoms such as confusion and sweating.He ate 2 eggs for breakfast and was still feeling unwell.The customer's wife called paramedics, who ran blood test on their meter and obtained a reading of 59 mg/dl at 7:42 a.M.Paramedics gave strawberry juice and a slice of bread to the customer to increase his blood glucose levels, after which he felt better.At 9:10 a.M., paramedics ran another test on their meter and obtained a reading of 79 mg/dl.The customer was advised to return the test strips for evaluation.Replacement meter and test strips were sent to the customer.
Additional Manufacturer Narrative
The customer returned the suspected contour meter and contour test strips from lot # 8bj3b04d for evaluation.An in-house testing was performed using the returned meter with returned test strips, 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: 9261736
• Report Number: 1810909-2019-00475
• Device Sequence Number: 16765719
• Product Code: NBW
• UDI-Device Identifier: 10301937098502
• UDI-Public: 10301937098502
• 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): 10/02/2019

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: 02/29/2020
• Device Model Number: 7098C
• Device Catalogue Number: 7098C
• Device Lot Number: 8BJ3B04D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR