(b)(6) clinic receiving multiple error 407 (failure of onboard controls) for roche coaguchek xs plus meter while using test strips with lot number 49408211 and expiration 3/31/2022.An estimate of at least 10 failures were noted out of a vial of one to two vials (24 test strips per vial).Not all test strips from the affected vials failed.Test strip reported error message 407 once a droplet of blood was applied.Machine immediately displayed error 407 and would not record a result.This was noted on multiple roche coaguchek xs plus machines but multiple pharmacists performing the point of care testing.This occurred while testing multiple patients (not all errors were related to one patient.) roche has been notified of the concern, and we have been asked to send vials with failing test strips back to roche for further testing/analysis.Fda safety report id # (b)(4).
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