Model Number STRIP, TMX WGN 50CTMG/DL #348014 |
Device Problems
Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/13/2022 |
Event Type
malfunction
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Event Description
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Consumer reported complaint for physical defect of test strips.Customer stated he has two vials (of the same lot number) of test strips and that the test strips in both vials are bent and sticking together.The customer feels well and did not report any symptoms.No medical intervention related to the use of the product was reported.
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Manufacturer Narrative
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Internal report reference number: (b)(4).Test strips were not returned for evaluation.Note: manufacturer contacted customer in several follow-up calls to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.
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Manufacturer Narrative
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Sections with additional information as of 28-march-2022.H6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: meter was not returned for evaluation.Test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strips tested within specifications.Most likely underlying root cause: mlc-028: there was not enough information to determine the mlurc.
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Search Alerts/Recalls
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