Model Number N/A |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The cause for the discordant syphilis (syph) results is unknown.Siemens healthcare diagnostics has requested the patient sample for further testing and investigation.The ifu states in the limitations section: a (b)(6) test result does not exclude the possibility of exposure to or infection with syphilis.T.Pallidum antibodies may be undetectable in some stages of the infection and in some clinical conditions.Assay performance characteristics have not been established for the atellica im syph assay used in conjunction with other manufacturers' assays for specific syphilis serological markers." mdr 1219913-2019-00134 (repeat result on (b)(4)) and mdr 1219913-2019-00135 (repeat result on (b)(4)) were filed for the same event.
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Event Description
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A discordant (b)(6) atellica im syphilis (syph) result was obtained for a patient sample.The patient sample was repeated on both atellica im systems on a different date and the results were (b)(6).The initial detection of treponemal antibodies at the emergency service was (b)(6).Testing on an alternate method yielded (b)(6) results.Confirmatory testing was performed.The tpha result was indeterminate and the fta result was (b)(6).The rpr result was (b)(6).Patient treatment was not altered or prescribed.There was no report of adverse health consequences due to the discordant atellica im syphilis (syph) results.
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Manufacturer Narrative
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Siemens filed the initial mdr 1219913-2019-00133 on july 19, 2019.Siemens filed the mdr 1219913-2019-00133 supplemental report 1 on october 04, 2019.10/07/2019 correction: for section d suspect medical device, the incorrect lot# was documented.The correct lot# is 30659057 and the correct expiration date is 08-01-2020.No further evaluation of the device is required.Mdr 1219913-2019-00134 (repeat result on s/n: (b)(6), mdr 1219913-2019-00134 supplemental report 1 (repeat result on s/n: (b)(6), mdr 1219913-2019-00135 (repeat result on s/n: (b)(6), and mdr 1219913-2019-00135 supplemental report 1 (repeat result on s/n: (b)(6) were filed for the same event.
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Manufacturer Narrative
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Siemens filed the initial mdr 1219913-2019-00133 on (b)(6) 2019.09/19/2019 additional information: the patient sample was received by siemens and tested with atellica im syphilis reagent lot 128060.The sample was also processed with a scantabodies nabt (non-specific antibody blocking tube) tube to test for non-specific interferents in a particular sample.Results: date: (b)(6) 2019 patient id reagent lot neat result (index) pt 128060 0.65 (negative).Date: (b)(6) 2019 pt nabt: rgt lot 128060 nabt result (index) interpretation rep 1 0.66 negative.Rep 2 0.69 negative.Rep 3 0.64 negative.The index of the sample did not change significantly.Based on the information provided and the results of the investigation, siemens is unable to rule out a sample specific issue.The atellica im syphilis (b)(4).Rev.03, 2017-12) states "the results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation and other findings.A nonreactive test result does not exclude the possibility of exposure to or infection with syphilis.T.Pallidum antibodies may be undetectable in some stages of the infection and in some clinical conditions." based on the information provided a product problem was not identified.The instrument is performing within specifications.No further evaluation of the device is required.Mdr 1219913-2019-00134 supplemental report 1 (repeat result on (b)(4) and mdr 1219913-2019-00135 supplemental report 1 (repeat result on (b)(4) were filed for the same event.
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Search Alerts/Recalls
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