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	Loss of consciousness (2418)
Date of Event	01/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 at 12:00 a.M.He obtained a blood glucose reading of 374 mg/dl with his contour meter.The customer stated that he did not eat anything for 7 hours prior to the event.The customer took 3 units of long-lasting insulin based on the reading of 374 mg/dl.During the night after administering insulin, the customer passed out.The customer's family member gave him soda after which he recovered well.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 customer returned the suspected contour meter and contour test strips from lot # 0aj3b01c for evaluation.The returned meter was tested with the returned test strips using a blood sample, which gave a 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: 11273737
• Report Number: 1810909-2021-00065
• Device Sequence Number: 17014609
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2021

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: 01/31/2022
• Device Model Number: 7080G
• Device Catalogue Number: 7080G
• Device Lot Number: 0AJ3B01C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR