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

Model Number	7151H
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2020
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 age and weight were not provided.
Event or Problem Description
The customer alleged to have purchased a contour meter in us and found that the meter was reading in mmol/l.There was no allegation of an adverse event.The customer was advised to return the device for evaluation.Replacement meter kit and test strips were sent to the customer.
Additional Manufacturer Narrative
The customer did not return the device for evaluation.Therefore, a device manufacturing record was reviewed for the suspected contour meter and no manufacturing anomalies were found.Section h4 of the initial report indicated the device manufacture date for the contour meter with serial # (b)(6) as 14-apr-2005.The correct device manufacture date is 26-oct-2008.Section h4 has been updated with the correct information.
Additional Manufacturer Narrative
The customer returned the suspected contour meter and contour test strips for evaluation.However, the returned meter did not switch on even after changing the batteries.Therefore, the in-house testing could not be performed.

• 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: 10949157
• Report Number: 1810909-2020-00625
• Device Sequence Number: 11468265
• Product Code: NBW
• UDI-Device Identifier: 00301937151019
• UDI-Public: 00301937151019
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 11/06/2020

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 Model Number: 7151H
• Device Catalogue Number: 7151H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2021
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 12/08/2020; 04/24/2021
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 01/06/2021; 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1