MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP TOXOPLASMA M (TOXO M) ASSAY; TOXO M 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	08/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the discordant negative advia centaur xp toxoplasma m result is unknown.Siemens is investigating.The instructions for use (ifu) under the interpretation of results section states the following: "the detection of toxoplasma igm in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity." the instructions for use (ifu) under the limitation section states the following: "patient specimens collected very early during the acute phase of infection may contain toxoplasma igm levels below the cutoff of the advia centaur toxo m assay.Additionally, diagnosis of a recent infection should not be made based on a single sampling because igm antibodies to t.Gondii may persist in serum many months after infection.The presence of igm antibodies to t.Gondii is not diagnostic for recent infection.Mdr 1219913-2017-00256 was filed for the same complaint from a new sample draw on a different day for the same patient.
Event or Problem Description
A false negative advia centaur xp toxoplasma m (toxo m) result was obtained by the customer on a patient known to be pregnant.The negative toxo m result considered discordant compared to a positive reference laboratory test method result.The patient sample was sent to the reference laboratory for further testing, and the toxo m result was positive.A corrective report was issued.The same patient was redrawn at a later date ((b)(6) 2017), and the advia centaur xp toxo m result was negative (refer to mdr 1219913-2017-00256).There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant advia centaur xp toxo m result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2017-00255 on (b)(6) 2017 for a false negative advia centaur xp toxoplasma m (toxo m) patient result.On (b)(6) 2018 additional information: siemens has requested further information for investigation, however none has been provided.The cause false negative advia centaur xp toxoplasma m (toxo m) patient result is unknown, and it appears to be sample/patient specific.Siemens is not aware of other false negative advia centaur xp toxoplasma m (toxo m) patient results with reagent lot 080278.The instrument is performing within specifications.No further investigation is required.Mdr 1219913-2017-00256 was filed for the same patient for a redrawn sample, and mdr 1219913-2017-00256 supplemental report 1 for additional information.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2017-00255 on 12/11/2017 for a false negative advia centaur xp toxoplasma m (toxo m) result, and mdr 1219913-2017-00255 supplemental 1 on 01/22/2018 for additional information.02/02/2018 - correction: siemens was informed by the customer that the reference in relevant tests/lab data to a new sample collected on (b)(6) 2017 was in error.There was no new sample or patient result.The instrument is performing within specifications.No further investigation is required.Mdr 1219913-2017-00256 was filed for a false negative advia centaur xp toxoplasma m (toxo m) result on a redrawn sample.Mdr 1219913-2017-00256 supplemental report 1 was filed for additional information and mdr 1219913-2017-00256 supplemental report 2 was filed for the same relevant tests/lab data correction.

• Brand Name: ADVIA CENTAUR XP TOXOPLASMA M (TOXO M) ASSAY
• Common Device Name: TOXO M IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7106826
• Report Number: 1219913-2017-00255
• Device Sequence Number: 1874214
• Product Code: LGD
• UDI-Device Identifier: 00630414208442
• UDI-Public: 00630414208442
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K010755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2018

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: 10/27/2017
• Device Model Number: N/A
• Device Catalogue Number: 10310320
• Device Lot Number: 080278
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/24/2017
• Supplement Date Received by Manufacturer: 01/17/2018; 02/02/2018
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 01/22/2018; 02/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR