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

Model Number	9556C
Medical Device Problem Code	Missing Test Results (3267)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient/family was the initial reporter, so personal information was not entered.
Event or Problem Description
The customer initially called for assistance with suspected high readings.The complaint did not meet the criteria to be reported.During the call when accessing the memory to view the readings, the customer was not able to find the readings, and alleged the contour was not retaining them.No adverse event was alleged.The customer was advised to return the meter for evaluation.A new meter was sent to her.
Additional Manufacturer Narrative
The returned meter was tested with the returned and in-house test strips and all results were correctly stored in the meter memory.The customer did indicate that she had replaced the battery recently.When replacing the battery on the contour meter, if the battery is removed from the device for more than five minutes, the memory will be lost.This is a possible explanation for why the customer was not able to see her prior stored results.

• Brand Name: CONTOUR
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC; 430 s beiger st; mishawaka IN 46544
• MDR Report Key: 7794682
• Report Number: 1826988-2018-00189
• Device Sequence Number: 19144709
• 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): 07/31/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1