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

Model Number	7097C
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient/family was the initial reporter, so personal information was not entered.
Event or Problem Description
At 5:56 p.M., the customer obtained blood glucose readings of 13 mg/dl and 159 mg/dl on a contour meter.The customer had no symptoms of hypoglycemia.There was no allegation of an adverse event.The customer stated that she used all the test strips from the affected lot, therefore, the test strips are not expected to be returned.A replacement meter kit was sent to the customer.
Additional Manufacturer Narrative
The customer only returned the suspected contour meter.An in-house testing was performed using the returned meter with in-house contour test strips from lot # 7lj3d01u, which gave 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: 8730459
• Report Number: 1810909-2019-00272
• Device Sequence Number: 19400870
• Product Code: NBW
• UDI-Device Identifier: 10301937097505
• UDI-Public: 10301937097505
• 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): 05/30/2019

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 Expiration Date: 11/30/2019
• Device Model Number: 7097C
• Device Catalogue Number: 7097C
• Device Lot Number: 7LJ3D01U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 08/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR