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 03/22/2019 |
Event Type
malfunction
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Manufacturer Narrative
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A siemens field service engineer went on site and performed a total service visit.The ahbs2 assay was calibrated and qc testing was performed.Calibration and qc passed.Siemens continues to investigate.The ifu states in the interpretation of results section: "results should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings.".
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Event Description
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Customer observed an advia centaur xp anti-hbs2 (ahbs2) result that was elevated and (b)(6) and did not match the clinical picture of the patient.The physician questioned the result.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur xp ahbs2 result.
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Manufacturer Narrative
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Mdr 1219913-2019-00057 was filed reporting an elevated advia centaur xp anti-hbs2 result that did not match the clinical picture of the patient.Additional information - may 23, 2019.While the issue was corrected by performing the acid and base decontamination, the cause of the contamination was not determined.The system is now performing as designed.Root cause of the imprecision with advia centaur xp ahbs2 lot 102 was an issue resolved with normal instrument troubleshooting.Based on the investigation, no product problem was identified.
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Search Alerts/Recalls
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