Model Number 7151A |
Device Problem
Nonstandard Device (1420)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/24/2022 |
Event Type
malfunction
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Event Description
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A healthcare professional called on behalf of the customer to report that the customer alleged to have purchased a contour meter in us and found that the meter was reading in mmol/l instead of mg/dl.There was no allegation of an adverse event.The health care professional was advised to return the device for evaluation.A replacement kit was sent to the customer.
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Manufacturer Narrative
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No information was captured in as the customer's age and weight were not provided.The device identifier # was left blank as it could not be determined based on the available model #.The contact information for the initial reporter was not provided, therefore, no information was captured.
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Manufacturer Narrative
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The customer did not return the device for evaluation.Therefore, the device history record was reviewed for the suspected contour meter and no manufacturing anomalies were found.Additionally, it was determined that the suspected meter was not intended for release in the us market.The meter was most likely intended for the canadian market.
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Search Alerts/Recalls
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