Model Number IMMULITE 2000/IMMULITE 2000 XPI BR-MA |
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 10/26/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Siemens is evaluating the issue.
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Event Description
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Siemens technical operations internal investigation has identified that discordant falsely low results were obtained on two investigational samples on an immulite 2000/ immulite 2000 xpi instrument when using the br-ma (ca15-3) assay.The two investigational samples were spiked with biotin at multiple concentrations and run for investigational purposes on an immulite 2000/immulite 2000 xpi instrument.The results of the two samples spiked with 500 ng/ml of biotin were falsely low with a bias of -73% and -53% respectively compared to results of the two samples without biotin.There were no patient samples impacted as this was for investigational purposes only.
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Manufacturer Narrative
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The initial mdr 2432235-2017-00614 was filed on 17-nov-2017.Additional information (06-dec-2017): siemens healthcare diagnostics has confirmed that biotin interferes with the ca15-3 (br-ma) on the immulite 2000/immulite 2000 xpi platform.At biotin concentrations of >100 ng/ml a negative bias that exceeds 10% has been observed on immulite 2000/immulite 2000 xpi platforms.This issue affects previously manufactured, in-date, and future lots.The immulite 2000/immulite 2000 xpi platform instructions for use (ifu's) currently do not have biotin listed as a potential interferent.An urgent field safety notice (ufsn) imc 18-02.A.Ous was sent out to ous customers and an urgent medical device recall (umdr) imc18-02.A.Us was sent to us customers on december 13, 2017.The ufsn and umdr informs the customers of biotin interference on all affected immulite assays.Siemens will update all ifu's with the appropriate biotin information.
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Manufacturer Narrative
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Corrected information (12/18/2017): based on input from the philadelphia recall coordinator on 12/18/2017 this recall was re-submitted to the new york office (oradevices1recalls@fda.Hhs.Gov).The crr reporting number indicated is incorrect and was changed to 2432235-12/19/2017-004-c.In addition it was indicated that an "urgent medical device recall (umdr) was sent to us customers.This is incorrect as an "urgent medical device correction (umdc)" was sent to us customers on december 13, 2017.
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Search Alerts/Recalls
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