The customer observed a falsely elevated ca19-9 result on the architect i2000sr analyzer.The following data was provided: initial 88 u/ml, repeat 115 u/ml, 118 u/ml.Data from another method was also included: 8 u/ml and 9 u/ml on roche method and 9 u/ml and 9 u/ml on diasorin method.The female patient was referred to the hospital for imaging studies and an endoscopy.The imaging studies were normal and showed no signed of cancer.No further patient details were able to be obtained.
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A returned patient sample was provided by the customer and specificity testing was conducted with the suspect medical device.Two different studies were conducted on the sample.First, of the manual dilutions prepared, one of the three dilutions indicated evidence of a potential interferent.Second, when the returned sample was treated with a heterophilic blocking tube (hbt), the results of the testing indicates the interference was due to heterophilic antibodies.Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling, and accuracy testing.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.An internal panel was tested with retained kits of the likely cause reagent lot and accuracy testing met all specifications.Based on all available information and abbott diagnostics' complaint investigation, the assay performed as intended and no product deficiency was identified.
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The conclusion code was corrected to (b)(4).The device evaluation was reassessed and concluded that a malfunction occurred, therefore, the device was not performing as intended, however, no systemic issue or product deficiency was identified.
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