MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT SYPHILIS (SYPH); SYPHILIS IMMUNOASSAY

Model Number	N/A
Medical Device Problem Codes	False Negative Result (1225); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) to report discordant, false nonreactive advia centaur xpt syphilis (syph) results when tested with rehydrated blood spot samples.Siemens has completed the investigation.The only available sample types for the testing of blood samples with the advia centaur® syph assay are human serum and plasma (edta, lithium-heparin, sodium-heparin, citrate).The customer has been informed that rehydrated blood spot samples are a non-supported sample type.The instrument has been verified to have no mechanical deficiencies.The instructions for use (ifu) under the specimen collection and handling section states the following: "serum and plasma (edta, lithium heparin, sodium heparin, and citrate) are the recommended sample types for this assay." the instructions for use (ifu) under the limitations section states the following: "the advia centaur syph assay is limited to the detection of antibodies to t.Pallidum in human serum or plasma (edta, lithium or sodium heparinized plasma, citrated plasma)." the instructions for use (ifu) under the interpretation of results states the following: "results should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings.The assay is performing within specifications.No further evaluation of the device is required.
Event or Problem Description
Discordant, false nonreactive advia centaur xpt syphilis (syph) repeat results were obtained from a rehydrated blood spot sample after an initial syph reactive result.The nonreactive repeat results were tested with a different rehydrated blood spot sample.The customer performed repeat testing with an alternate rpr (non-treponemal) test method on another rehydrated blood spot sample, resulting reactive.The syph results were not reported to the physician(s).There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant, nonreactive advia centaur xpt syphilis (syph) results.

• Brand Name: ADVIA CENTAUR XPT SYPHILIS (SYPH)
• Common Device Name: SYPHILIS IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 11933825
• Report Number: 1219913-2021-00336
• Device Sequence Number: 3831457
• Product Code: LIP
• UDI-Device Identifier: 00630414580173
• UDI-Public: 00630414580173
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2021

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: 11/17/2021
• Device Model Number: N/A
• Device Catalogue Number: 10492493
• Device Lot Number: 082
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1