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

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of an elevated advia centaur xp total hcg (thcg) result for one patient which was discordant relative to repeat-testing results.Following observation of an elevated initial advia centaur xp thcg result, the patient was re-tested at another laboratory and produced a negative result.The customer then performed repeat thcg testing on the original sample in duplicate, using the same advia centaur xp instrument as used initially, and a result of <2.0 miu/ml was obtained.The lower result was accepted as correct.There are no allegations of patient harm, changes in treatment, or delays in diagnosis in association with the observed result discordance.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of an elevated advia centaur xp total hcg (thcg) result for one patient which was discordant relative to repeat-testing results.Following observation of an elevated initial advia centaur xp thcg result, the patient was re-tested at another laboratory and produced a negative result.The customer then performed repeat thcg testing on the original sample in duplicate, using the same advia centaur xp instrument as used initially, and a result of <2.0 miu/ml was obtained.The instructions for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens is investigating.
Additional Manufacturer Narrative
Mdr 1219913-2022-00104 was filed on 2022-04-07.Additional information, 2022-05-26: siemens has concluded the investigation.A customer from outside the united states reported observation of an elevated advia centaur xp total hcg (thcg) result for one patient which was discordant relative to repeat-testing results.Repeat-testing using the same method produced consistent lower results.The customer also repeat-tested 7 samples which had been initially tested for thcg on the day of this event and all repeat results were consistent with the initial results.The customer's advia centaur xp thcg reagent calibration and control results were acceptable on the day of this event.A service visit was made to the customer site, with the following findings: error-log review: no entries found to explain observed variation.Verification of quality control performance: satisfactory results were observed during this period.Verifications of calibrations in effect at time of observation: values were consistent with expectations/criteria.Testing of hcg samples in different ranges: satisfactory results were obtained without any observed clinical deviation.Siemens service made the following recommendations to the customer regarding sample handling: minimize delay between collecting and centrifuging sample tubes.Verify duration and rpm of centrifugation.Assess whether there has been any change to the storage/handling of the sample tubes.· check expiration dates of collection tubes, and note whether tubes used are at or near expiration.While siemens cannot definitively determine the cause of the discordant result, contributing factors such as sample integrity cannot be ruled out.Based on the results of the investigation, return of the patient sample is not warranted.A product performance issue has not been identified.The customer is operational; no further investigation is required.Note: in section h6, the codes for investigation findings and investigation conclusion have been updated.

• Brand Name: ADVIA CENTAUR XP TOTAL HCG
• Common Device Name: TOTAL HCG 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: barry ; 333 coney street; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 14047389
• Report Number: 1219913-2022-00104
• Device Sequence Number: 4908297
• Product Code: JHI
• UDI-Device Identifier: 00630414505176
• UDI-Public: 00630414505176
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K200210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/02/2022
• Device Model Number: N/A
• Device Catalogue Number: 10308985
• Device Lot Number: 335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Sex: Female