MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM TOXOPLASMA IGM (TOXO M); TOXOPLASMA GONDII IMMUNOGLOBULIN M IMMUNOASSAY

Model Number N/A

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2022

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted a siemens customer care center (ccc) to report discordant, non-reactive atellica im toxoplasma igm (toxo m) results were obtained from four patients that were considered discordant compared to results generated with a different lot of atellica im toxoplasma igm (toxo m).Qc was low at the time of testing.The atellica im toxoplasma igm (toxo m) instructions for use (ifu) states the following, under the interpretation of results section: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens healthcare diagnostics is investigating.

Event Description

The customer observed atellica im toxoplasma igm (toxo m) non-reactive (negative) results from four samples that were considered discordant compared to results generated with a different lot of atellica im toxoplasma igm (toxo m).The results were questioned by the physician(s).There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant, non-reactive atellica im toxoplasma igm (toxo m) results.

Manufacturer Narrative

The initial mdr 1219913-2022-00096 was filed on march 30, 2022.Additional information - april 29, 2022.An outside the united states customer observed atellica im toxoplasma igm (txom) non-reactive (negative) results from four samples that were considered discordant compared to results generated with a different lot of atellica im toxoplasma igm (txom).Siemens performed a study with 20 samples.These samples had known results based on an alternate method.4 of these samples were txom positive and 16 were negative on txom reagent lots 381 and 383.These samples results were concordant with both lots and with the alternate method.Another study was performed and a panel of 21 samples were tested with atellica im txom lots 373, 375, 378, 379, 381 and 383.All samples recovered the same interpretation results throughout all these txom lots.Siemens reviewed field patient data and lot 383 is recovering similarly with other lots.Siemens continues to investigate.

Manufacturer Narrative

The initial mdr 1219913-2022-00096 was filed on march 30, 2022.Mdr 1219913-2022-00096 supplemental 1 was filed on may 20, 2022.Additional information - june 3, 2022; an outside the united states customer noted lower recovery with quality control (qc) and patient samples with atellica im (aim) 1600 toxoplasma igm (txom) lot 383 compared to lot 381.Siemens reviewed the customer's siemens qc recovery and it was within insert ranges for both levels and with both txom lots.The customer did a correlation study with 6 patient samples close to the cut-off of 1.0 index and 4 of them recovered non-reactive with lot 383, while they were reactive with lot 381.Siemens performed an internal study with a panel of 21 samples that were tested with atellica im txom lots 373, 375, 378, 379, 381 and 383.All samples recovered with the same interpretation results throughout all these txom lots.Siemens performed an additional study with (b)(4) acquired from france.These samples had known results based on an alternate method.4 of these samples were toxm positive and 16 were negative with txom reagent lots 381 and 383.These sample results were concordant with both lots and with an alternate method.The total number of reactive results the customer has reported with txom lot 383 was not provided and the sensitivity cannot be calculated.Based on the available information, atellica im txom lot 383 is performing as intended and no product performance issue has been identified.The customer is operational, and no further action required.In section h6, an additional type of investigation code was added and the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA IM TOXOPLASMA IGM (TOXO M)
• Type of Device: TOXOPLASMA GONDII IMMUNOGLOBULIN M IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney street; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 13957462
• MDR Text Key: 289211742
• Report Number: 1219913-2022-00096
• Device Sequence Number: 1
• Product Code: LGD
• UDI-Device Identifier: 00630414600147
• UDI-Public: 00630414600147
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K010755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2022
• Device Model Number: N/A
• Device Catalogue Number: 10995701
• Device Lot Number: 383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1