Model Number 7308 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/22/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A device history record for contour next test strips lot # 9cpeg09a was reviewed and no anomalies were found.The maintenance log showed normal adjustments, and the vial line challenges and line clearance were successful.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.
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Event Description
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The customer opened a box of contour next test strips and the bottle was already open.There was no allegation of an adverse event.The customer was advised to return the test strips for evaluation.Replacement test strips were sent to the customer.
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Manufacturer Narrative
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The customer returned the suspected contour next test strips from lot # 9cpeg09a for evaluation.The contour next test strips user guide instructs the user to discard all test strips and not to use them if the cap is opened on a newly opened box of strips.The bottle of 50 contour next test strips arrived for investigation with only 25 strips in the bottle.In-house testing was performed using the returned test strips with in-house contour next one meter, which gave a satisfactory performance.
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Search Alerts/Recalls
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