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 01/04/2019

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant toxoplasma g (toxo g) results is unknown.Siemens healthcare diagnostics is investigating.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 1219913-2019-00025 and mdr 1219913-2019-00026 were filed for the same event.

Event Description

False positive advia centaur xp toxoplasma g (toxo g) results were obtained on three different draws from the same patient.The positive results were found to be discordant with the current results from an alternate method and historical negative results.The physician questioned the positive results.The toxo m results were always 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 1219913-2019-00024 on february 22, 2019.On 02/28/2019 correction: for sections b5 and b6, false positive advia centaur xp toxoplasma g (toxo g) results were obtained on two different draws from the same patient and not three draws.Samples dated from 01/04/2019 1:02 pm and 01/28/2019 7:09 pm are the same but the customer renamed the sample id for the rerun for the system.On 03/13/2019 additional information: the quality control (qc) and adjustments were confirmed to be within range.The type of blood collection tube used was bd vacutainer 3.5 ml sst(tm) ii pet tube with clot activator (silica) and separating gel, with paper label and golden cap.The samples were tested on the same day of blood collection, at least 30 minutes of coagulation, and spun at 1800g for 12 minutes.The customer had a patient sample that repeatedly recovered positive on the advia centaur xp toxoplasma g (toxo g) lot 061236 and non-reactive with alternate methods.A new sample was drawn at a later day and still recovered positive with the advia centaur xp toxoplasma g (toxo g) lot 236.The sample handling was in accordance with the advia centaur xp toxoplasma g (toxo g) instructions for use (ifu) (b)(4) recommendations.The sample was not available to be sent to the manufacturer for further evaluation and the sample was not tested with a heterophilic blocking tubes (hbt).While there is insufficient information to determine the cause of the reproducible false positive results on the advia centaur xp, it seems to be a patient sample specific instance.Possible heterophiles present in the sample can affect the quality of the sample and lead to erroneous results.The customer was unable to provide the total number of negative samples the customer has tested with advia centaur xp toxoplasma g (toxo g) lot 236 so the specificity that the customer is seeing cannot be calculated.Based on the available information the advia centaur xp toxoplasma g lot 061236 is performing as intended.The instrument is performing within specifications.No further evaluation of the device is required.Mdr 1219913-2019-00025 supplemental report 1 and mdr 1219913-2019-00026 supplemental report 1 were filed for the same event.

• 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: 8364092
• MDR Text Key: 139219680
• Report Number: 1219913-2019-00024
• Device Sequence Number: 1
• Product Code: LGD
• UDI-Device Identifier: 00630414962238
• UDI-Public: 00630414962238
• 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
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2019
• Device Model Number: N/A
• Device Catalogue Number: 10310321
• Device Lot Number: 236
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 21 YR