MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY; TOXOPLASMA GONDII IMMUNOASSAY

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/15/2019

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics is investigating the cause for the discordant toxoplasma g (toxo g) results.The ifu states in the limitations section: "in geographic regions that have an apparent low prevalence of toxoplasma igg in asymptomatic populations, the positive predictive value of any assay is reduced due to the increased possibility that a positive result is actually falsely positive.As with all in vitro diagnostic assays, each laboratory should determine its own reference range(s) for the diagnostic evaluation of patient results." mdr 1219913-2019-00028 was filed for the same event (initial testing).

Event Description

A false positive advia centaur xp toxoplasma g (toxo g) result was obtained on a sample from a pregnant patient on the date of delivery.The patient sample was tested on an alternate methods and western blot.The results were negative.The patient was tested again and the result was positive.The historical results were negative from an unknown method.The toxoplasma m result was negative.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant toxoplasma g results.

Manufacturer Narrative

Siemens filed the initial mdr on (b)(6) 2019.05/15/2019 additional information: the customer had a sample of a patient that recovered reactive (positive) on advia centaur xp toxoplasma g (toxo g) lot 238 on the date of delivery (childbirth (b)(6) 2019, 3:56 am).The same sample was repeated on the advia centaur xp toxoplasma g (toxo g) lot 238 a few days later and was repeatedly reactive but non-reactive with alternate methods.The patient during her pregnancy had 6 different monthly draws and toxo g always recovered non-reactive when tested with the same advia centaur xp system.Siemens reviewed customer's adjustments and quality control (qc) data and those were within ranges and comparable with release data.Sample handling was in accordance with the advia centaur xp toxoplasma g instructions for use (ifu) 10629904_en rev.Aa, 2016-04 recommendations.The sample is not available to be send in for further evaluation and the sample was not tested with a heterophilic blocking tubes (hbt).Taken into consideration the number of reactive and non-reactive samples the customer reported with toxoplasma g lot 238, the calculated specificity for this account with toxoplasma g lot 238 is 159/160= 0.9937 x100= 99.4 %.The relative specificity results from the 3 studies in the advia centaur xp toxoplasma g ifu range from 99.3% - 99.8%.The customer has not reported any new incidents of false reactive (positive) toxoplasma g results and this issue is considered to be an isolated and sample specific incident.Based on the available information advia centaur xp toxoplasma g lot 238 is performing as intended.The instrument is performing within specifications.No further evaluation of the device is required.Mdr 1219913-2019-00028 supplemental report 1 was filed for the same event (initial testing).

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2019-00035 on march 05 2019.Siemens filed the mdr 1219913-2019-00035 supplemental report 1 on may 17, 2019.06/06/2019 correction: clarification of historical results were provided.The historical results were from non-siemens platforms.Due to the clarification of the historical results, the statement in the mdr 1219913-2019-00035 supplemental report 1 that states "the patient during her pregnancy had 6 different monthly draws and toxo g always recovered non-reactive when tested with the same advia centaur xp system.", should state "the patient during her pregnancy had 6 different monthly draws and toxo g always recovered non-reactive when tested at a different laboratory with non-siemens platforms." the ifu states in the interpretation of results section: "the detection of toxoplasma igg in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity." 06/13/2019 additional information: the patient did not return for a new draw, despite several calls from the biologist.No further evaluation of the device is required.Mdr 1219913-2019-00028 supplemental report 2 was filed for the same event (initial testing).

• Brand Name: ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY
• Type of Device: TOXOPLASMA GONDII IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 8391649
• MDR Text Key: 139220979
• Report Number: 1219913-2019-00035
• Device Sequence Number: 1
• Product Code: LGD
• UDI-Device Identifier: 00630414208459
• UDI-Public: 00630414208459
• Combination Product (y/n): N
• PMA/PMN Number: K102681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2019
• Device Model Number: N/A
• Device Catalogue Number: 10310321
• Device Lot Number: 85337238
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/15/2019
• Initial Date FDA Received: 03/05/2019
• Supplement Dates Manufacturer Received: 05/15/2019; 06/06/2019
• Supplement Dates FDA Received: 05/17/2019; 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 30 YR