Catalog Number 02K91-28 |
Device Problem
Low Test Results (2458)
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Patient Problem
No Code Available (3191)
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Event Date 10/03/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4): diagnostic imaging performed, it's unknown if iv contrast was used, or the impact to patient management.An evaluation is in process.A follow up report will be submitted when the evaluation is complete.An evaluation is in process.
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Event Description
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The customer observed a falsely depressed ca19-9 result on the architect i2000sr analyzer.The patient ((b)(6)) has not been diagnosed with pancreatic cancer and is suspected to have ovarian cancer.The following data was provided: initial 15.46, repeat 15.20 u/ml.A value of 270 was obtained on another method at another facility.The patient underwent an image diagnosis and it is unknown if iv contrast was used.No further details regarding the patient or procedure could be obtained.
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Manufacturer Narrative
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On (b)(6) 2016 additional information was provided by the customer.The imaging was performed due to the other hospitals results.The ca19-9 results did not cause the imaging.Based upon this new information, this complaint is no longer a reportable event.
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Search Alerts/Recalls
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