Model Number IMMULITE/IMMULITE 1000 ANTI-TG AB |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/27/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The customer contacted a siemens customer care center and stated that they ran quality control prior to running the patient sample, which was acceptable.A siemens headquarters support center specialist stated that the immulite 1000 anti-tg ab instructions for use has no claims for correlation of the immulite 1000 results with the results obtained on the alternate platform.The cause of the discordant anti-tg ab result on one patient sample is unknown.Siemens is investigating the issue.
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Event Description
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The customer obtained a discordant result for anti tg (thyroglobulin) autoantibodies (anti-tg ab) on one patient sample when run on an immulite 1000 instrument, while using reagent lot 0260.The result obtained on the immulite 1000 instrument was interpreted to be nondetectable for thyroglobulin antibodies.The sample was repeated on an alternate platform, resulting different from that obtained on the immulite 1000 instrument.The result obtained on the alternate platform was interpreted as detectable for thyroglobulin antibodies.The result obtained on the immulite 1000 instrument was reported to the physician(s), who questioned it.The correct result obtained on the alternate platform was reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant anti-tg ab result.
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Manufacturer Narrative
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The initial mdr 2432235-2017-00279 was filed on april 21, 2017.Additional information (05/02/2017): upon further investigation, a siemens headquarters support center (hsc) specialist stated that the differences in antigens, antibodies, assay architecture, and assay standardizations can cause differences between results with different manufacturer's assays.The cause of the discordant anti-tg ab result on one patient sample is unknown.The device is performing within manufacturing specifications.No further evaluation of device is required.
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Search Alerts/Recalls
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