Model Number 07P4830 |
Device Problem
Low Test Results (2458)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/23/2020 |
Event Type
malfunction
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Manufacturer Narrative
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An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
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Event Description
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The customer stated that a falsely decreased alinity i tsh result of 0.1 miu/ml was generated for a patient sample (b)(6).The same sample tube was tested on a different alinity i processing module and the result was 67 miu/ml which matched the clinical picture.No adverse impact to patient management was reported.
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Manufacturer Narrative
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No customer returns were available.Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.Complaint searches determined that there is normal complaint activity for the likely cause lot.Labeling was reviewed and found to be adequate.Testing of panels which mimic patient samples was performed using an in-house retained kit and all specifications were met indicating the lot is preforming acceptably.Based on the available information, no product deficiency was identified.
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Search Alerts/Recalls
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