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Model Number REF 04625315160 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/31/2021 |
Event Type
malfunction
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Event Description
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Coaguchek xs pt test strips: strip is loaded, sample added and then it beeps and requires new sample/strip.Meter is fine and usually the second sample reads fine; occurred 6-7 times from the same tube of test strips.Fda safety report id# (b)(4).
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Search Alerts/Recalls
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