Device Problem
Missing Information (4053)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/11/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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.Since the labeling information was missing, no information was captured (part #, lot # and expiration date), and the device manufacture date could not be determined.
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Event Description
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The customer stated that he received the contour test strips and alleged that the label information i.E.Lot #, part #, expiration date, and control ranges were missing from the label of the vial of the test strips.There was no allegation of an adverse event.The customer was advised to return the device for evaluation.Replacement meter kit and test strips were sent to the customer.
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Manufacturer Narrative
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The customer did not provide the suspected product for evaluation.In addition, since no product information or pictures were provided, the device history record could not be reviewed.
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Search Alerts/Recalls
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