Lot Number 1AM3F06A |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/17/2022 |
Event Type
malfunction
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Event Description
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The customer from (b)(6) reported that he opened a box of the contour ts test strips and the bottle was already open.There was no allegation of an adverse event.Replacement test strips were sent to the customer.The customer was advised to return the device for evaluation.
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Manufacturer Narrative
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A device history record was reviewed for the suspected contour ts test strips and no manufacturing anomalies were found.The dimensions of the carton makes it difficult for a vial cap to open after packaging when the box is sealed.The patient/family was the initial reporter, so personal information was not entered.No information was captured as the customer's weight was not provided.The model # was not provided.
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Manufacturer Narrative
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A device history record was reviewed for the suspected contour next test strips and no manufacturing anomalies were found.The dimensions of the carton makes it difficult for a vial cap to open after packaging when the box is sealed.
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Search Alerts/Recalls
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