BECTON, DICKINSON & CO. (SPARKS) BD BACTEC FX, INSTRUMENT TOP, PACKAGED; SYSTEM, BLOOD CULTURING
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Model Number 441385 |
Device Problem
Device Ingredient or Reagent Problem (2910)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that while using bd bactec¿ fx, instrument top, packaged a false positive result was obtained by the laboratory personnel.A differential test was used to confirm the results as false positives.The customer stated results were not reported out so there was no report of patient impact.
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Manufacturer Narrative
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H.6.Investigation: customer reported false positive issue on a bd bactec fx top instrument (p/n 441385, s/n (b)(6).No erroneous results were reported to doctors, and patients were not impacted.The application teacher guided the experiment operation and solved the problem.Review of the device history record is not required due to the age of the instrument.Service history record review revealed no previous complaints for this issue.Bd quality did not receive any returned parts or instrument for investigation.This complaint is an unconfirmed failure of a bd product.The root cause is unable to be determined.See h.10.
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Event Description
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It was reported that while using bd bactec¿ fx, instrument top, packaged a false positive result was obtained by the laboratory personnel.A differential test was used to confirm the results as false positives.The customer stated results were not reported out so there was no report of patient impact.
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