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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the elevated total hcg result is unknown.The elevated result was not reproducible.Preanalytical sample handling or a possible sample mix up cannot be ruled out since repeat testing of the initial sample yielded a negative thcg result.Service was sent on site.The technician inspected the system and found crystalized serum around the sample dispense port on the incubation ring cover.He cleaned the buildup and performed an incubation ring empty and fill to confirm that there was no remaining dried serum in any of the unused cuvettes.He performed qc with all results in range and returned the system to operation.Buildup of dried serum around the opening can eventually fall off the cover into the sample cuvette.This may cause contamination of the test sample.The interpretation of results section of the instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".
Event or Problem Description
Customer observed a non-reproducible, elevated advia centaur xp total hcg (thcg) result.The elevated result was reported to the physician and the physician questioned the result.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur xp thcg result.

• Brand Name: ADVIA CENTAUR XP TOTAL HCG (THCG)
• Common Device Name: TOTAL HCG
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; tarrytown NY 10591
• MDR Report Key: 6700820
• Report Number: 1219913-2017-00151
• Device Sequence Number: 11135592
• Product Code: JHI
• UDI-Device Identifier: 00630414505152
• UDI-Public: 00630414505152
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K92577
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 07/11/2017

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: 09/07/2017
• Device Model Number: N/A
• Device Catalogue Number: 1030894
• Device Lot Number: 41046290
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2017
• Initial Report FDA Received Date: 07/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 13 YR