BECTON, DICKINSON & CO. (SPARKS) BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED; SYSTEM, BLOOD CULTURING
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Model Number 441385 |
Device Problem
False Negative Result (1225)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/08/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: na.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that the bd bactec¿ fx, instrument top, packaged produced a false negative result.There was no indication of confirmatory testing, or that results were reported to clinicians.There was also no report of patient impact.The following information was provided by the initial reporter, translated from (b)(6) to english: "results problems.3 false negatives." "it was found that in all the graphs there were low fluorescence readings since their entry and later they fell even more.In one case, evidence was found that the vial had been entered into the equipment 13 hours after taking the sample.In the other two cases, there was no data on the time the sample was taken.It is concluded that the vials were entered into the equipment in a delayed manner long after the sample had been taken.Recommendations are given for the collection of complete data and for the case that they receive delayed samples.".
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Event Description
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It was reported that the bd bactec¿ fx, instrument top, packaged produced a false negative result.There was no indication of confirmatory testing, or that results were reported to clinicians.There was also no report of patient impact.The following information was provided by the initial reporter, translated from spanish to english: "results problems.3 false negatives." "it was found that in all the graphs there were low fluorescence readings since their entry and later they fell even more.In one case, evidence was found that the vial had been entered into the equipment 13 hours after taking the sample.In the other two cases, there was no data on the time the sample was taken.It is concluded that the vials were entered into the equipment in a delayed manner long after the sample had been taken.Recommendations are given for the collection of complete data and for the case that they receive delayed samples.".
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Manufacturer Narrative
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This supplemental is to cancel mfr# 1119779-2021-01912.Further information has changed the reportability and the complaint is no longer reportable.
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Search Alerts/Recalls
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