MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP FOLATE (FOL) ASSAY; FOLATE IMMUNOASSAY

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	07/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics is investigating.The ifu states in 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
Discordant advia centaur xp folate results were obtained on a patient sample between neat and dilution, the initial result was greater than 24 ng/ml.The sample was diluted and tested multiple times.The results were lower with dilution.The sample was tested again diluted on a second advia centaur xp and the result was lower than the neat result.The diluted results were considered correct.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant folate results.
Additional Manufacturer Narrative
08/30/2017: additional information: there is no information on the patient medication.There is no new sample available for the patient to be tested.The patient sample (b)(6) was tested on an alternate method and the result was (b)(6).The testing on the advia centaur xp gave a mean result of 5.6 with a 20% cv after 1/5 or 1/10 dilution.Siemens is unable to determine the cause of the non-linear dilutions because there is no sample available to be returned.Additionally, there is no information about patient medication or if the patient had taken vitamins or supplements.The instrument is performing within specifications.No further evaluation of the device is required.The ifu states in the limitations section: "hemolysis significantly increases folate values due to the high folate concentrations in red blood cells.Methotrexate and leucovorin interfere with folate measurement because these drugs cross-react with folate binding proteins.".

• Brand Name: ADVIA CENTAUR XP FOLATE (FOL) ASSAY
• Common Device Name: FOLATE IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 6789785
• Report Number: 1219913-2017-00171
• Device Sequence Number: 16386138
• Product Code: CGN
• UDI-Device Identifier: 00630414450940
• UDI-Public: 00630414450940
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K010050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2017

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: 12/20/2017
• Device Model Number: N/A
• Device Catalogue Number: 10325366
• Device Lot Number: 50532254
• Initial Date Received by Manufacturer: 07/24/2017
• Supplement Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 08/11/2017
• Supplement Report FDA Received Date: 09/19/2017
• Patient Sequence Number: 1
• Patient Age: 16 YR