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

Model Number	7080G
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2020
Type of Reportable Event	Malfunction
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
An advocate reported that the customer obtained blood glucose reading of 14 mg/dl at 8:27 a.M., and 110 mg/dl at 8:29 a.M.On the contour meter.The customer did not presented symptoms of hypoglycemia.There was no allegation of an adverse event.The advocate 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 for evaluation.No test strips were retuned.Therefore, the contour test strips from lot # 0hj3b02c were used for in-house testing as the suspected lot of test strips i.E.Lot # 8mj3b01b expired in dec-2020.The returned meter was tested with the in-house test strips using a blood sample, which gave a satisfactory performance.Additionally, a device history record was reviewed for the suspected contour meter and no manufacturing anomalies.

• 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: 10719182
• Report Number: 1810909-2020-00564
• Device Sequence Number: 3433321
• 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): 10/01/2020

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: 12/31/2020
• Device Model Number: 7080G
• Device Catalogue Number: 7080G
• Device Lot Number: 8MJ3B01B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1