MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT TOTAL HCG ASSAY; TOTAL HCG IMMUNOASSAY

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2018

Event Type  malfunction  

Manufacturer Narrative

The cause of the non-reproduced false low advia centaur xpt total human chorionic gonadotropin (hcg) result is being investigated by siemens.The instruction for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the instruction for use (ifu) under the limitation section states the following: "all in vitro assays can generate erroneous results, both clinically false positive results (test results suggesting a condition that is absent) and clinically false negative results (test results failing to identify a condition that is present)." "there are many possible causes for these types of discordant results.Erroneous results may occur due to interference from identifiable serum constituents or patient-specific serum constituents." "if an aberrant or abnormal result, as defined by the laboratory protocol, occurs, laboratory personnel should first make certain that the system is performing and is operated and maintained in accordance with the product labeling.The user should then follow the laboratory protocol for advising the clinician of a result that appears to have deviated from the norms established by the laboratory." "test results alone are not diagnoses of medical conditions.For example, low titer elevations of hcg can occur in normal non-pregnant subjects.A physician's diagnosis involves evaluation of the test result in conjunction with, and in the context of, the patient's medical history, physical examination, and other test results sometimes in consultation with other medical experts.".

Event Description

A false low advia centaur xpt total human chorionic gonadotropin (hcg) result obtained by the customer on a patient sample, and reported to the physician.The physician did not question the result, however a second sample was drawn two days later, and the advia centaur xpt result was higher.The original sample was diluted, hcg testing repeated, and the result was also higher.A corrected report was issued by the customer.There was no report of patient treatment being prescribed or altered, or adverse health consequences due to the discordant advia centaur xpt total hcg result.

Manufacturer Narrative

Siemens filed mdr on 11/20/2018 for a false low advia centaur xpt total human chorionic gonadotropin (hcg) result obtained by the customer on a patient sample.12/05/2018: additional information: the cause for the false low total human chorionic gonadotropin (hcg) result is unknown.Quality control (qc) and other patient samples were not affected.The observed issue is sample specific to this patient.The sample is not available for further investigation.The cause for the low hcg result may be attributed to high dose hook effect.The instruction for use (ifu) under the high-dose hook effect section states the following: "patient samples with high hcg levels can cause a paradoxical decrease in the rlus (high-dose hook effect).In this assay, patient samples with hcg levels as high as 400,000 miu/ml (iu/l) will assay greater than 1000 miu/ml (iu/l)." the instruction for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the instruction for use (ifu) under the limitation section states the following: "all in vitro assays can generate erroneous results, both clinically false positive results (test results suggesting a condition that is absent) and clinically false negative results (test results failing to identify a condition that is present)." "there are many possible causes for these types of discordant results.Erroneous results may occur due to interference from identifiable serum constituents or patient-specific serum constituents." "if an aberrant or abnormal result, as defined by the laboratory protocol, occurs, laboratory personnel should first make certain that the system is performing and is operated and maintained in accordance with the product labeling.The user should then follow the laboratory protocol for advising the clinician of a result that appears to have deviated from the norms established by the laboratory." "test results alone are not diagnoses of medical conditions.For example, low titer elevations of hcg can occur in normal nonpregnant subjects.A physician's diagnosis involves evaluation of the test result in conjunction with, and in the context of, the patient's medical history, physical examination, and other test results sometimes in consultation with other medical experts." the instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XPT TOTAL HCG ASSAY
• Type of Device: TOTAL HCG IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 8090358
• MDR Text Key: 129329356
• Report Number: 1219913-2018-00273
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 00630414505176
• UDI-Public: 00630414505176
• Combination Product (y/n): N
• PMA/PMN Number: K925277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2018
• Device Model Number: N/A
• Device Catalogue Number: 10308985
• Device Lot Number: 029298
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/31/2018
• Initial Date FDA Received: 11/20/2018
• Supplement Dates Manufacturer Received: 12/05/2018
• Supplement Dates FDA Received: 12/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1