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

Model Number 10995701

Device Problem False Negative Result (1225)

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

Event Date 06/08/2023

Event Type  malfunction  

Manufacturer Narrative

A customer from outside the united states reported observation of a false negative atellica im toxoplasma igm (toxo m) result which was discordant relative to repeat testing of the same sample.Following observation of the identified discordant negative result among a series of positive results, the instrument in question was subjected to service, including acid-pump replacement (preventive maintenance), and successful checks of washing station, acid priming, and system start-up.Quality control (qc) results were as expected, and no issues were observed with later routine testing.There are no known reports of patient intervention or adverse health consequences due to the apparent false negative toxo m result.The atellica im toxoplasma igm (toxo m) instructions for use (ifu) states the following, under interpretation of results: "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

A customer reported observation of a negative atellica im toxoplasma igm (toxo m) result which was discordant relative to repeat testing.An initial positive toxoplasma igm (toxo m) result was obtained.The same sample was repeat-tested on an alternate atellica im 1600 analyzer, which produced a negative result.The same sample was again repeated on the initial analyzer and produced a positive result.The same sample was then repeated on the second analyzer, returning a positive result.The positive result was considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the apparent false negative toxo m result.

Manufacturer Narrative

Mdr 2432235-2023-00150 was initially submitted 2023-06-13.Update, 2023-07-25: siemens has concluded the investigation.A customer from outside the united states reported observation of a false negative atellica im toxoplasma igm (toxo m) result which was discordant relative to repeat testing of the same sample.Following observation of the identified discordant negative result among a series of positive results, the instrument in question was subjected to service, which included minor parts replacement and a number of adjustments and interventions.Assay calibration and quality control (qc) results were reported to be within acceptable ranges, but data were not provided for review.Siemens reviewed internal assay data, and determined that toxo m lot 398 met all applicable release criteria, and was comparable to other reagent lots.Additional information was requested multiple times, but not provided.The customer¿s effective assay sensitivity cannot be estimated.Siemens reviewed field patient data and determined that result distributions for kit lot 398 were comparable to those of other lots.The identified non-reproducible result appears to be an isolated event.No product issue has been identified, and the local issue was resolved by routine service intervention.The customer is operational, and no additional action is required.Note: in section h6, the codes for investigation findings and investigation conclusion have been 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
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 511 benedict ave.; tarrytown, NY 10591 ; 5082985306
• MDR Report Key: 17116947
• MDR Text Key: 318078541
• Report Number: 2432235-2023-00150
• Device Sequence Number: 1
• Product Code: LGD
• UDI-Device Identifier: 00630414600147
• UDI-Public: 00630414600147
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 08/01/2023

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: 10/13/2023
• Device Model Number: 10995701
• Device Catalogue Number: 10995701
• Device Lot Number: 398
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2023
• Initial Date FDA Received: 06/13/2023
• Supplement Dates Manufacturer Received: 07/25/2023
• Supplement Dates FDA Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2023
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1