|
Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 05/12/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
The cause for the discordant (b)(6) results is unknown.Siemens has received samples for testing.The advia centaur/xp/xpt hbsagii information for use (ifu) states in the limitations section: "heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.Patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous values may be observed.Additional information may be required for diagnosis.For diagnostic purposes, the advia centaur hbsagii test results should always be assessed in conjunction with the patient's medical history, clinical examination, and other findings." the advia centaur/xp/xpt hbsagii information for use (ifu) states in the interpretation of results section: "samples with an index value of >/= 1.0 but =50 are considered reactive (positive) for hbsag.The test must be repeated in duplicate.If 2 of the 3 results are nonreactive, the sample is considered negative for hbsag.If at least 2 of the 3 results are reactive, the sample is repeatedly reactive, and the presence of hbsag should be confirmed with the advia centaur hbsag confirmatory assay, additional hbv marker assays, or another approved confirmatory method." the results section of the advia centaur hbsag confirmatory information for use (ifu) states: "for diagnostic purposes and to differentiate between acute and chronic hbv infection, the detection of hbsag should be correlated with patient clinical information and other hbv serological markers.It is recognized that current methods for detection of hepatitis b surface antigen may not detect all potentially infected individuals.A false reactive hbsagii test result or invalid confirmatory result does not exclude the possibility of exposure to or infection with hepatitis b." mdr 1219913-2018-00174 is being filed for sample test results generated on may 15, 2018 for the same patient.
|
|
Event Description
|
The customer observed initial (b)(6) results that were (b)(6).(b)(6) results were not confirmed.Additional testing of the same sample and a subsequent sample from the same patient yielded (b)(6) results and not confirmed conf results.A previous (b)(6) result was (b)(6).The customer stated that a result of (b)(6) was reported to the physician.The patient is a dialysis patient.Based on the (b)(6) results, the patient was placed on a dialysis machine that is used for patient with (b)(6) results.There are no reports of adverse health consequences due to the (b)(6) results.The patient is now deceased due possible kidney failure.Mdr 1219913-2018-00174 is being filed for sample test results generated on may 15, 2018 for the same patient.
|
|
Manufacturer Narrative
|
Siemens filed mdr 1219913-2018-00162 on june 14, 2018 reporting the observation of initial advia centaur xpt hbsagii results that were (b)(6) but did not confirm with the advia centaur xpt hbsagii confirmatory test.Mdr 1219913-2018-00174 was filed for sample test results generated on (b)(6) 2018 for the same patient.June 29, 2018 - additional information (b)(6).The advia centaur/xp/xpt hbsagii information for use (ifu) states in the limitations section: "heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.Patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous values may be observed.Additional information may be required for diagnosis.For diagnostic purposes, the advia centaur hbsagii test results should always be assessed in conjunction with the patient's medical history, clinical examination, and other findings." the results from the plasma samples did not confirm the results from the serum tube.No further investigation is required.Mdr 1219913-2018-00174 was filed for sample test results generated on (b)(6) 2018 for the same patient.Mdr 1219913-2018-00174 supplemental report 1 is filed with the results of siemens' testing as well.
|
|
Search Alerts/Recalls
|
|
|