|
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 05/15/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
The cause for the discordant advia centaur xp hbsagii 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 1219913-2018-00162 is being filed for sample test results generated on (b)(6) 2018 for the same patient.
|
|
Event Description
|
The customer observed initial advia centaur xpt hbsagii results that were (b)(6).Advia centaur xpt hbsagii confirmatory (conf) results were not confirmed.Additional testing of the same sample and a subsequent sample from the same patient yielded (b)(6) advia centaur xpt hbsagii results and not confirmed conf results.A previous advia centaur hbsagii 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) advia centaur xpt hbsagii 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) advia centaur xpt hbsagii results.The patient is now deceased due to possible kidney failure.Mdr 1219913-2018-00162 is being filed for sample test results generated on (b)(6) 2018 for the same patient.
|
|
Manufacturer Narrative
|
Siemens filed mdr 1219913-2018-00174 on june 14, 2018 reporting the observation of initial advia centaur xpt hbsagii results that were reactive but did not confirm with the advia centaur xpt hbsagii confirmatory test.Mdr 1219913-2018-00162 was filed for sample test results generated on may 12, 2018 for the same patient.June 29, 2018 - additional information.Siemens received the original serum sample (sid (b)(6)) as well as three (3) individual plasma samples from the same patient and tested them using advia centaur hbsagii reagent lot 109140.Serum sample (b)(6); 1.16 index - reactive (unable to retest in duplicate due to limited sample volume).Plasma sample (b)(6) 1.16 index, 0.79 index, 0.75 index - 2 out of 3 results are less than 1.Index, therefore the sample is non-reactive.Plasma sample (b)(6); 0.59 index - nonreactive.Plasma sample (b)(6); 0.57 index - nonreactive.Results of testing plasma sample (b)(6) with a heterophilic blocking tube were inconclusive, however, the initial result was 0.59 index before treatment and ,0.10 index after treatment which is indicative of a heterophilic interferent being present in the sample causing a false reactive result.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 1219913-2018-00162 was filed for sample test results generated on (b)(6) 2018 for the same patient.Mdr 1219913-2018-00162 supplemental report 1 is filed with the results of siemens' testing as well.
|
|
Search Alerts/Recalls
|
|
|