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	03/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the covid-19 pandemic, the investigation for this event will be delayed.We will however, send the follow-up report as soon as our laboratory services are able to return to normal.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.
Event or Problem Description
The customer reported that there was a difference of 20 to 30 mg/dl between the blood glucose readings obtained on the contour meter and another meter.No specific readings were provided.There was no allegation of an adverse event.The customer was advised to return the device 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 did not return the device for evaluation.Since the lot # for the affected test strips was not provided, the in-house testing could not be performed.Therefore, 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
• MDR Report Key: 9884199
• Report Number: 1810909-2020-00154
• Device Sequence Number: 14140893
• 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
• 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
• Report Date (Section B): 03/02/2020

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?: No
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR