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Model Number XS |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/20/2020 |
Event Type
malfunction
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Event Description
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I was using coagucheck by roche to test my inr.I've had multiple instances where i can't get a result; 4 test strips and multiple error codes on today's attempt.I've had the same issues in the past where i've used up to 7 strips for 1 result.Concerned the results i'm getting aren't accurate at all.If it's taking so many strips why is just 1 working ok? fda safety report id# (b)(4).
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Search Alerts/Recalls
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