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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. CONTOUR; BLOOD GLUCOSE METER
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ASCENSIA DIABETES CARE US INC. CONTOUR; BLOOD GLUCOSE METER Back to Search Results
Model Number 9545C
Medical Device Problem Code Missing Test Results (3267)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/26/2020
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 reported that one of his blood glucose readings was not stored in the memory of the contour meter.There was no allegation of an adverse event.The customer was advised to return the device for evaluation.The customer was offered a replacement device, however, the customer declined.
 
Additional Manufacturer Narrative
The customer did not return the device for evaluation.Therefore, a device history record was reviewed for the suspected contour meter and no manufacturing anomalies were found.
 
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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 Key10566642
Report Number1810909-2020-00494
Device Sequence Number16935868
Product Code NBW
UDI-Device Identifier00301939545014
UDI-Public00301939545014
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K062058
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date (Section B) 08/26/2020
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 Number9545C
Device Catalogue Number9545C
Initial Date Received by Manufacturer 08/26/2020
Supplement Date Received by Manufacturer12/08/2020
12/08/2020
Initial Report FDA Received Date09/22/2020
Supplement Report FDA Received Date12/09/2020
12/10/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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