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

Model Number	9556C
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient details were not provided, therefore, no information was captured.
Event or Problem Description
The paramedics called to report that they performed a blood glucose test on a patient with their contour meter and obtained a reading of 98 mg/dl.Upon repeat testing with the hospital's meter, a reading of 36 mg/dl was obtained.No further event details were provided.There was no allegation of an adverse event.No follow-up could be established with the paramedics, therefore, no replacement product was sent.The device is not expected to be returned.Since the strip information was not provided, this report will be submitted under the meter information.
Additional Manufacturer Narrative
The customer did not return the suspected product for evaluation.Therefore, in-house contour test strips were tested with the in-house contour meter, which gave satisfactory performance.

• 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: 8850236
• Report Number: 1810909-2019-00320
• Device Sequence Number: 16215796
• Product Code: NBW
• UDI-Device Identifier: 00301939556010
• UDI-Public: 00301939556010
• 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: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2019

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: Health Professional
• Device Model Number: 9556C
• Device Catalogue Number: 9556C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/04/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1