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

Model Number	7080G
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the covid-19 pandemic, the investigation for this event will be delayed.We will however, send the follow-up report as soon as our laboratory services are able to return to normal.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
The customer reported that he took 25 units of insulin at 2:25 a.M.At 5:48 a.M., the customer performed a blood glucose test and obtained a hi reading (indicative of a reading above 600 mg/dl) on the contour meter.Within 5 minutes, the customer obtained a reading of 77 mg/dl on another meter.The customer had no symptoms of hyperglycemia.There was no allegation of an adverse event.The customer was advised to return the device for evaluation.Replacement meter kit and test strips were sent to the customer.
Additional Manufacturer Narrative
The manufacturing address in section g1,2 (continued) of the initial report was captured incorrectly.Section g1,2 (continued) has been updated.
Additional Manufacturer Narrative
The customer returned the suspected contour meter and contour test strips from lot # 9bj3b07a for evaluation.The customer also returned contour next ez meter, which was not implicated to be associated with the event.In-house testing was performed using the returned contour meter with returned contour test strips, and returned contour next ez meter with in-house contour next test strips, which gave a satisfactory performance.
Additional Manufacturer Narrative
A device history record was reviewed for the suspected contour meter and no manufacturing anomalies were found.

• Brand Name: CONTOUR
• Common Device Name: BLOOD GLUCOSE TEST STRIPS
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla, ny
• MDR Report Key: 10083020
• Report Number: 1810909-2020-00263
• Device Sequence Number: 2899909
• Product Code: NBW
• UDI-Device Identifier: 10301937080507
• UDI-Public: 10301937080507
• 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,Followup,Followup
• Report Date (Section B): 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Model Number: 7080G
• Device Catalogue Number: 7080G
• Device Lot Number: 9BJ3B07A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Initial Date Received by Manufacturer: 04/30/2020
• Supplement Date Received by Manufacturer: 06/03/2020; 07/15/2020; 07/20/2020
• Initial Report FDA Received Date: 05/22/2020
• Supplement Report FDA Received Date: 06/03/2020; 07/17/2020; 08/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR