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

Model Number	N/A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics is investigating the cause of the discordant afp result.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.".
Event or Problem Description
A false high advia centaur xp afp result was obtained for a patient sample.The patient sample was repeated and the results were negative.The negative result was reported to the physician.Patient has a medical history of thyroid cancer.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant afp results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2019-00277 on december 17, 2019.On 01/14/2020 additional information: the customer refused to do precision analysis and no further assistance is required on this issue.On 01/17/2020: siemens has completed the investigation into a falsely elevated afp result.The sample initially read 9.2 ng/ml on lot 214 but when repeated was 2.1 and 2.2.Quality control (qc) was within range and the same reagent readypack was used for initial and repeat testing.No other samples were affected, and the customer is running without further issue.The customer is not interested in performing additional precision studies.Siemens is unable to rule preanalytical variables that may have contributed to the initial higher result.Should the customer observe further samples, we highly recommend a precision study be performed.In house data was reviewed for lot 214 and no fliers were observed in the release data.No product nonconformance was identified.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP AFP ASSAY
• Common Device Name: AFP IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 9482585
• Report Number: 1219913-2019-00277
• Device Sequence Number: 3542008
• Product Code: LOJ
• UDI-Device Identifier: 00630414177335
• UDI-Public: 00630414177335
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K020806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2020

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: 05/08/2020
• Device Model Number: N/A
• Device Catalogue Number: 10309980
• Device Lot Number: 42197214
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR