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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 7151H
Medical Device Problem Code Nonstandard Device (1420)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/08/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A device history record (dhr) was reviewed for the suspected contour meter and no manufacturing anomalies were found.As per the dhr, the meter was set with the correct units of measurement i.E.Mg/dl.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 the us and found that the meter was reading in mmol/l.There was no allegation of an adverse event.The meter is not expected to be returned for evaluation.
 
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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 Key10649760
Report Number1810909-2020-00532
Device Sequence Number14256940
Product Code NBW
UDI-Device Identifier00301937151019
UDI-Public00301937151019
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)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/10/2020
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 Number7151H
Device Catalogue Number7151H
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/10/2020
Initial Report FDA Received Date10/08/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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