BECTON DICKINSON & CO. (SPARKS) BD MAX¿ STAPHSR; SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCC
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Catalog Number 443419 |
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 08/24/2023 |
Event Type
malfunction
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Event Description
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It was reported that while using bd max¿ staphsr that there was a false negative.The following information was provided by the initial reporter: 3 samples that channels nuc (530/565 nm) and meca/mecc (585/630 nm) were positive, but mrej (475/520 nm) remained negative.
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Manufacturer Narrative
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E.1 initial reporter e-mail: (b)(6).H.3.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 while using bd max¿ staph that there was a false negative.The following information was provided by the initial reporter: 3 samples that channels nuc (530/565 nm) and meca/mecc (585/630 nm) were positive, but mrej (475/520 nm) remained negative.
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Manufacturer Narrative
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After further evaluation of the complaint, it has been determined that the previously submitted report 1119779-2023-01018 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore, this is not considered to be a reportable malfunction.
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Search Alerts/Recalls
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