Catalog Number 03507432190 |
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 02/09/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Unique identifier (udi)#: (b)(4).
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Event Description
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The customer received questionable igg-2 tina-quant igg gen.2 results for one patient sample from cobas 8000 c 502 module serial number (b)(4).The initial result was 9.3 mg/dl with a data flag and was reported outside the laboratory as <30 mg/dl.The repeat result with an increased sample volume was 888.4 mg/dl with a data flag.A second sample from the patient was tested and the result was 903 mg/dl.This result was reported outside the laboratory and was believed to be correct.The physician called and questioned the first result because he had expected the igg to be high and because the result on the second draw was reported out as the high value.The patient was not adversely affected.The customer refused a service visit and stated he did not believe there was a hardware issue.
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Manufacturer Narrative
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A specific root cause could not be identified.No sample material was available for further testing.The calibration trace did not show any issues.Interference due to a gammopathy was possible but unlikely as the igm result was in the normal range at 42 mg/dl.After further investigation, no general interference was suspected.The customer said that the sample was a short draw so it was poured off into a micro cup for testing.Numerous alarms were noted that indicate an issue with appropriate sample volumes in the cups.The event may have been caused by sample mispipetting due to gel particulates.The customer confirmed they have not had any issues with other samples or applications.
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Search Alerts/Recalls
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