BECTON, DICKINSON & CO. (SPARKS) BD BACTEC FX, INSTRUMENT TOP, PACKAGED; SYSTEM, BLOOD CULTURING
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Model Number 441385 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/02/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: na.Initial reporter phone #: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported while testing with bd bactec¿ fx, instrument top, packaged potential false positive vials were obtained.It is unknown what type of confirmation testing was performed.There was no report of patient impact.
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Manufacturer Narrative
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Investigation summary: customer reported false positive issue on a bd bactec fx top instrument (p/n 441385, s/n ft7680).No erroneous results were reported to doctors, and patients were not impacted.Customer indicated that the equipment released 22 false positive vials.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.No new trends, risks, or hazards were identified as a result of the complaint.Bd quality will continue to closely monitor for trends associated with this failure.H3 other text : see h10.
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Event Description
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It was reported while testing with bd bactec¿ fx, instrument top, packaged potential false positive vials were obtained.It is unknown what type of confirmation testing was performed.There was no report of patient impact.
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