Catalog Number 443712 |
Device Problem
False Positive Result (1227)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/05/2023 |
Event Type
Injury
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Manufacturer Narrative
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D2: common device name: vaginitis and bacterial vaginosis nucleic acid detection system.A2: age or date of birth: date of birth was not available so on (b)(6) has been used.H.3.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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Report 2 of 2 it was reported that while using bd max¿ vaginal panel, a false positive result was obtained.The patient was treated with metronidazole and fluconazole.The following information was provided by the initial reporter: patient 2: 34 year old woman.Dx: infertility consult.Treated with metronidazole and fluconazole." patient 2: on (b)(6) 2023 - ct0176 - v5.20.Run#: 7616 in a1.K46 3137707 2024-04-16.Bv neg.C group pos.Ckru pos.Cgla pos.Tv tos.Max vaginal panel - 443712_3137707 - fps.
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Event Description
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Report 2 of 2.It was reported that while using bd max¿ vaginal panel, a false positive result was obtained.The patient was treated with metronidazole and fluconazole.The following information was provided by the initial reporter: patient 2: 34 year old woman; dx: infertility consult; treated with metronidazole and fluconazole".Patient 2.(b)(6) 2023 - (b)(6) - v5.20; run #7616 in a1; k46 3137707 2024-04-16.Bv neg.C group pos.Ckru pos.Cgla pos.Tv tos.Max vaginal panel - (b)(6) - fps.
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Manufacturer Narrative
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H.6.Investigation summary: the complaint investigation for discrepant results with the bd max¿ vaginal panel (ref.443712) lot 3137707 was performed by the review of the manufacturing records, customer¿s data analysis and verification of complaints history.Review of the manufacturing records of bd max vaginal panel indicated that lot 3137707 was manufactured according to specifications and met performance requirements.Customer complained about two patient samples which obtained a positive result for all targets of the vaginitis master mix (mm2, bottom position of the cartridge) when using the bd max¿ vaginal panel assay kit lot 3137707.Customer provided run files (b)(4) and (b)(4) from instruments (b)(6) and (b)(6) respectively for investigation.Manual pcr curve adjudication was performed.The pcr curve pattern of the two samples tagged by the customer showed a step dislocation in the raw pcr signal, generated positive results for all targets in run (b)(4) (position b7) and (b)(4) (position a1).It is unlikely that the step dislocations are due to true amplifications.Moreover, additional information received from the customer revealed that the positivity rate did not increase in july, august and september 2023 suggesting isolated events.Bd was unable to identify a cause for the atypical pcr signal, but the issue appears to have been isolated.There is no indication of an increase in complaints for discrepant results for bd max vaginal panel lot 3137707.The root cause was not identified.Bd cannot confirm the complaint based on the investigation that was performed.
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Search Alerts/Recalls
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