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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2020
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
The customer reported that within 2 minutes, she obtained blood glucose readings of 559 mg/dl on the contour meter and 136 mg/dl on a non-ascensia meter.There was no allegation of an adverse event.The customer was advised to return the device for evaluation.A replacement meter kit was sent to the customer.
Additional Manufacturer Narrative
The customer returned the suspected contour test strips from lot #: 9lj3b03b for evaluation.The suspected contour meter was not returned.Therefore, the in-house contour meter was tested with the returned test strips using a blood sample.Which gave e2 error messages, indicative of insufficient blood.The in-house contour meter was then tested with the in-house contour test strips from lot #: j3b03b, using a blood sample.Which gave a satisfactory performance.The returned test strips were observed under microscope.However, the test strips did not look compromised or contaminated.The returned test strips will be further evaluated.
Additional Manufacturer Narrative
The event was further reviewed by analyzing the device history record for the suspected lot of test strips from lot # 9lj3b03b and no manufacturing anomalies were found.A surface analysis was performed on the returned test strips which showed silicon on the tips of the test strips.Silicon has a water repellent property, which may slow down filling of the test strips and may cause error messages and erratic test results.The cause of the event was attributed to the wrong usage of test strips by the customer.

• 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: 10503432
• Report Number: 1810909-2020-00451
• Device Sequence Number: 3055051
• Product Code: NBW
• UDI-Device Identifier: 10301937080507
• UDI-Public: 10301937080507
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 08/13/2020

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: 11/30/2021
• Device Model Number: 7080G
• Device Catalogue Number: 7080G
• Device Lot Number: 9LJ3B03B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 12/15/2020; 04/07/2021
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 01/04/2021; 04/09/2021
• Patient Sequence Number: 1
• Patient Age: 61 YR