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Model Number 221719 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/31/2023 |
Event Type
malfunction
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Manufacturer Narrative
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D.3 common device name: culture media, non-selective and differential.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 the bd bbl¿ urease test broth that there was a performance issue.The following information was provided by the initial reporter: customer problem: customer reported lot#: 3039044 showing no reaction at all when inoculated with proteus sp.Customer reports in the past they used to order the 10x concentration tubes (221098), but since they discontinued the product, they got product 221719 as an alternative.Customer reports they have at least received one previous lot of 221719 before nd it reacted normally, however when they changed to lot#: 3039044 , they have not gotten any reaction on any of the tubes.If consumable is tested on bd instrumentation, list serial numbers: lot#: 3039044.Hazard, injury or erroneous results? yes.Hazard, injury or erroneous results details no reaction.
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Event Description
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It was reported that while using the bd bbl¿ urease test broth that there was a performance issue.The following information was provided by the initial reporter: customer problem: customer reported lot#: 3039044 showing no reaction at all when inoculated with proteus sp.Customer reports in the past they used to order the 10x concentration tubes (221098), but since they discontinued the product, they got product 221719 as an alternative.Customer reports they have at least received one previous lot of 221719 before nd it reacted normally, however when they changed to lot#: 3039044 , they have not gotten any reaction on any of the tubes.If consumable is tested on bd instrumentation, list serial numbers: lot#: (b)(6).Hazard, injury or erroneous results? yes; hazard, injury or erroneous results details no reaction.
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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 1119779-2023-00468 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.H3 other text : see h.10.
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Search Alerts/Recalls
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