MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. CONTOUR NEXT; QUALITY CONTROL MATERIAL

Model Number	7315
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	11/29/2019
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.This event is related to mdr # 1810909-2019-00571.
Event or Problem Description
The customer reported that she performed control tests using the contour next link meter and obtained readings of 134 mg/dl and 88 mg/dl.The meter did not automatically mark them as control tests, and so the readings will be displayed as blood results when accessing the meter's memory.There was no allegation of an adverse event.The customer was advised to return the control solution for evaluation.Replacement meter kit and test strips were sent to the customer.
Additional Manufacturer Narrative
The customer returned the suspected contour next link meter, contour next test strips and contour next control solution from lot # 8bv1a17 for evaluation.An in-house testing was performed using the returned meter with returned test strips and control solution, which gave satisfactory performance.All control readings obtained during in-house testing were properly marked as control in meter's memory.
Additional Manufacturer Narrative
The customer did not return the suspected product for evaluation.Therefore, an in-house contour next link meter was tested with the in-house contour next test strips and in-house contour next control solution from lot # 8bv1a17, which gave satisfactory performance.All control readings obtained during in-house testing were properly marked as control in meter's memory.Additionally, a device history record was reviewed for the suspected contour next link meter and no manufacturing anomalies were found.

• Brand Name: CONTOUR NEXT
• Common Device Name: QUALITY CONTROL MATERIAL
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• MDR Report Key: 9481658
• Report Number: 1810909-2019-00570
• Device Sequence Number: 10865614
• Product Code: JJX
• UDI-Device Identifier: 10301937315012
• UDI-Public: 10301937315012
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151742
• 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,Followup
• Report Date (Section B): 12/02/2019

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: 06/30/2020
• Device Model Number: 7315
• Device Catalogue Number: 7315
• Device Lot Number: 8BV1A17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 02/05/2020; 02/11/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 02/07/2020; 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR