MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP PROGESTERONE (PRGE); PROGESTERONE IMMUNOASSAY

Model Number N/A

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2022

Event Type  malfunction  

Event Description

The customer obtained discordant advia centaur xp progesterone (prge) results on one patient sample that did not match the clinical profile.The physician questioned the initial result and the sample was retested in a reference laboratory with an alternate method.The result was lower and was more in line with patient clinical profile.A corrected report was issued.The customer retested the sample again on 2 different days using the advia centaur xp and using the alternate method.Results were similar to the initial results.There is no report that treatment was altered or prescribed or adverse health consequences due to the discordant, elevated prge results.

Manufacturer Narrative

A united states customer contacted the siemens customer care center to report discordant, elevated advia centaur xp progesterone (prge) results.The sample collection tube type was bd vacutainer with gel and clot activator and tube size was 13mm x 100mm.The customer confirmed there have been no known shipping/receiving or facility storage issues, and all reagents were handled in accordance with the assay instructions for use (ifu).The reagents were calibrated without issue and all levels of quality control (qc) resulted in range.The customer confirmed all instrument maintenance is current and there have been no signs of system contamination noted, but noted observations of random sample probe integrity errors.Siemens performed a total service call.Sample air pump, sample probe, and sample air tubing was replaced.The system was fully functional on departure.Qc and patients were tested after service and no intrument issues were observed.The limitation section of the ifu states: "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.The supplement dehydroepiandrosterone (dhea) may cause falsely elevated progesterone results in immunoassays.At an initial concentration of progesterone of (b)(4) change in concentration was observed at the supraphysiologic level of dheas (dhea metabolite) of (b)(4).For patients being treated with dhea, an alternate method that is not expected to show cross-reactivity to dheas (dhea metabolite), such as liquid chromatography-mass spectrometry (lc-ms), should be used.With the advent of new steroid-based medications (analogues) with similar chemical structure to progesterone, there is a possibility of cross-reactivity and falsely elevated results.For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination and other findings.If the progesterone results are inconsistent with clinical evidence, additional testing is suggested to confirm the result." siemens is investigating.Mdr 1219913-2022-00337 and mdr 1219913-2022-00339 were filed for the same issue.

Manufacturer Narrative

Siemens filed mdr 1219913-2022-00338 initial report on 2022-10-05.Additional information: 2022-11-10: siemens concluded the investigation for a united states customer observation of discordant, elevated advia centaur xp progesterone (prge) results and alleged that the results did not match the patient clinical profile.Sample retesting was performed with an alternate method at a reference laboratory.The alternate testing results recovered lower relative to the initial advia centaur prge results.The customer declined request to provide samples for an internal investigation and was not able to provide the patient clinical information.The customer has had no concerns with quality control (bio-rad immunoassay plus qc lot 40400) results.The limitations section of the advia centaur xp prge instructions for use contains the following statements: "the supplement dehydroepiandrosterone (dhea) may cause falsely elevated progesterone results in immunoassays." "for patients being treated with dhea, an alternate method that is not expected to show cross-reactivity to dheas (dhea metabolite), such as liquid chromatography-mass spectrometry (lc-ms), should be used.With the advent of new steroid-based medications (analogues) with similar chemical structure to progesterone, there is a possibility of cross-reactivity and falsely elevated results." "for diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination and other findings.If the progesterone results are inconsistent with clinical evidence, additional testing is suggested to confirm the result." results between two different platforms (centaur vs.Roche) may not be interchangeable, as evidenced by different reference ranges and control ranges between platforms.A review of siemens' internal medical decision pool (mdp) data for the impacted lot of advia centaur xp prge showed acceptable low-end performance.A review of the siemens complaint database did not identify any similar escalations with this lot of advia centaur xp prge.Based on the available information, a potential product performance issue has not been identified.The customer is operational and no further action is required.In section h6, investigation finding and investigation conclusion codes were updated based on the investigation results.Mdr 1219913-2022-00337 supplemental 1 and mdr 1219913-2022-00339 supplemental 1 were filed for the same issue.

• Brand Name: ADVIA CENTAUR XP PROGESTERONE (PRGE)
• Type of Device: PROGESTERONE IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney street; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 15547451
• MDR Text Key: 306611981
• Report Number: 1219913-2022-00338
• Device Sequence Number: 1
• Product Code: JLS
• UDI-Device Identifier: 00630414454641
• UDI-Public: 00630414454641
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: A836015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2022
• Device Model Number: N/A
• Device Catalogue Number: 10315522
• Device Lot Number: 307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• 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 Sex: Female