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

Model Number	9556C
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	11/28/2019
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 # 1810909-2020-00061.
Event or Problem Description
The customer reported that at 7:55 a.M., she obtained a blood glucose reading of 291 mg/dl on her contour meter.She performed another test at 8:00 a.M.With her contour next one meter and obtained a reading of 127 mg/dl.There was no allegation of an adverse event.The customer was advised to return the product for evaluation.Replacement meter and test strips were 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 next meter and contour next test strips from lot # 8kpeb01a for evaluation.The suspected contour meter was not returned.In-house testing was performed using the returned meter with returned test strips, which gave a satisfactory performance.A device history record was reviewed for the suspected contour meter and no manufacturing anomalies were found.

• 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: 9658936
• Report Number: 1810909-2020-00062
• Device Sequence Number: 11592962
• 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: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2020

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: 9556C
• Device Catalogue Number: 9556C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 03/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR