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

Model Number	9545C
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient/family was the initial reporter , so personal information was not entered.As the customer's age and weight were not provided.
Event or Problem Description
The customer reported that he performed a blood glucose testing on his contour meter and obtained a hi reading, which was indicative of a reading above 600 mg/dl.The customer had no symptoms of hyperglycemia.Within 2 minutes, the customer performed a repeat testing with the non-ascensia meter and obtained a reading of 128 mg/dl.There was no allegation of an adverse event.The customer was advised to return the test strips for evaluation, however, the customer discarded the test strips.A replacement meter kit was sent to the customer.Since the strip information was not provided, this report will be submitted under the meter information.
Additional Manufacturer Narrative
The customer returned the suspected contour meter for evaluation.No test strips were returned.An in-house testing was performed using the returned meter with in-house contour test strips, which gave satisfactory performance.Section d4 of the initial report indicates serial # for the suspected contour meter as f831952.The correct serial # is (b)(6).Section d4 has been updated with this information and section h4 has been updated with the correct device manufacture date.

• Brand Name: CONTOUR
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• MDR Report Key: 9144604
• Report Number: 1810909-2019-00434
• Device Sequence Number: 2568097
• Product Code: NBW
• UDI-Device Identifier: 00301939545014
• UDI-Public: 00301939545014
• 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): 09/12/2019

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 Model Number: 9545C
• Device Catalogue Number: 9545C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 10/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1