MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP TOTAL HCG

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 11/22/2017

Event Type  Injury  

Manufacturer Narrative

The patient is not taking any medications other than methotrexate.Siemens healthcare diagnostics has requested the patient samples for further testing and investigation.The customer will not be sending the patient samples for internal investigation.The customer stated that the physician does not require anything further.Additional information has been requested from the customer for investigation but was not provided.Based upon information obtained from the customer and evaluation performed by siemens to date, there is no indication of a product issue involving either the instrument or the assay.There is no confirmation that the hcg results are erroneous, such as a negative urine hcg result or hcg results from an alternate platform.Clinical presentation of suspected ectopic pregnancy, pelvic examination, patient hemodynamic stability, in addition to menstrual history, among others are important factors taken into account when evaluating suspected ectopic pregnancy.The first criteria in the diagnostic evaluation of ectopic pregnancy is confirming pregnancy.Once pregnancy is confirmed, if ectopic pregnancy is suspected hcg is typically repeated serially approximately every two days to assess whether the increase in hcg concentration is consistent with abnormal pregnancy.Tests used to diagnosis an ectopic pregnancy are a combination of hcg and transvaginal ultrasound (tvus).In this case, the customer did not provide any indication of the results of tvus diagnostics, such as an indication of pregnancy located in the fallopian tube or other location, or symptomology during assessment for abdominal pain (ex.Bleeding, etc).Ectopic pregnancy management depends on several factors.Treatment for ectopic pregnancy should not be performed based solely on a single assessment of tvus or hcg alone.Clinical information for the timeframe from (b)(6) after the initial indication of abdominal pain is unknown.Dilation and curettage may be performed if there is diagnostic uncertainty about whether a pregnancy is intrauterine or ectopic, prior to methotrexate or surgical treatment.Hcg is obtained prior to methotrexate treatment and then followed with serial hcg testing at two or more timepoints post-treatment to monitor for the pattern of change.If the hcg does not decrease sufficiently over a period of time, a second and/or third dose can be administered.It is common to observe an increase in hcg from day 1 through day 4 of methotrexate treatment.Failure of hcg to return to zero would prompt reassessment for a new pregnancy via tvus.The hcg concentration usually declines to low (ex.<15 miu/ml) levels by 35 days post-injection, but may take as long as 109 days for a patient with slow clearance.Surgical intervention is not the preferred method of treatment, but may be used if indicated, such as hemodynamic instability, suspicion of or risk factors for rupture, or failed medical therapy.The choice of surgery type relies upon many clinical factors, including ultrasound results.Hcg is monitored post-surgery for decline, and methotrexate may be administered prophylactically or when hcg does not decline to undetectable within a reasonable period of time.There were no adverse health consequences associated with the instrument or assay reported to siemens.The instrument and assay are performing within specifications.No further evaluation of the device is required.The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the ifu states in the limitations section: "this test may be used for detecting pregnancy by the first day of the missed menstrual period.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.Erroneous results due to interference are repeatable over time.Persistent serum hcg results in the range of 10 to 100 miu/ml (more typically 10 to 50 miu/ml) over several months suggests that the patient's blood may contain an interfering substance and produce erroneous results.Identified sources of interference that have the potential to bind to and interfere with any component of the assay include: -plasma components (clotting factors).-serum proteins (such as rheumatoid factor).-heterophile and anti-animal antibodies (such as anti-mouse, anti-rabbit, anti-goat).-anti-idiotype antibodies interference can also be caused by: -drugs and drug metabolites.-cross-reacting substances.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.This kit is not intended for any use other than assessment of pregnancy status." the following mdrs were filed for the same patient for different draws and results on different dates from the same complaint: mdr 1219913-2017-00246, mdr 1219913-2017-00247, mdr 1219913-2017-00248, mdr 1219913-2017-00249, mdr 1219913-2017-00251, mdr 1219913-2017-00252, mdr 1219913-2017-00253, and mdr 1219913-2017-00254.

Event Description

This is mdr 5 of 9 for the same patient with results from multiple draws on different days.Advia centaur xp total hcg positive results were questioned by the physician for a patient after it was determined that there was no pregnancy.The patient was first seen on (b)(6) in the er (emergency room) and a hcg qualitative test was performed using the cardinal sp combo kit (non-siemens method).The result was positive.The patient came in to the er (emergency room) on (b)(6) with abdominal pain.The patient sample was tested on the advia centaur xp for total hcg.The result was positive.The patient was again tested during a three day stay in the hospital from (b)(6).The total hcg was run on the advia centuar xp on (b)(6) and the results were positive.The patient was then tested on (b)(6) using the advia centaur xp total hcg assay and the result was positive.The patient was thought to have an ectopic pregnancy and was given methotrexate.The patient was retested on (b)(6) with the advia centaur xp total hcg and the result was positive.The patient then had a d&c (dilation and curettage) and tubal ligation.There is no pregnancy.She was retested again on (b)(6) on the advia centaur xp and the result was positive.The patient is currently being evaluated for tumors.The patient was given methotrexate.D&c and tubal ligation were performed.These procedures were not reported as adverse health consequences to siemens.Statements attributed to the clinicians are derived from information submitted to the siemens complaint handling system and have not been verified.

• Brand Name: ADVIA CENTAUR XP TOTAL HCG
• Type of Device: TOTAL HCG
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 5086604603
• MDR Report Key: 7139043
• MDR Text Key: 95591757
• Report Number: 1219913-2017-00250
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 00630414505176
• UDI-Public: 00630414505176
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2018
• Device Model Number: N/A
• Device Catalogue Number: 10308985
• Device Lot Number: 04682294
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 32 YR