MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TOXO IGM; ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII

Catalog Number	07028024190
Medical Device Problem Codes	False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The sample was requested for investigation.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys toxo igm results for 1 patient on a cobas 8000 e 801 module.The elecsys toxo igm result was 0.413 coi (negative).The toxo igg result was >650 iu/ml (positive).The elecsys toxo igg avidity showed low avidity.The sample was tested using the vidas (elfa) method, and the toxo igm result was 0.83 (positive).The unit of measure for this result was not provided.This result was believed to be correct.
Additional Manufacturer Narrative
The calibration and qc were acceptable.The sample was received for investigation.The investigation results were: the elecsys toxo igm result was 0.480 coi (non-reactive).The elecsys toxo igg result was >650 iu/ml (reactive).The elecsys toxo igg avidity result was 58 avi% (low).The result with the in-house neutralization assay was neutralizable (remaining titer of 14.8%).The neutralization assay confirmed the presence of specific toxoplasma igg antibodies in the patient¿s sample.The biorad platelia toxo igm result was 1.25 coi (reactive).The mikrogen toxo igm recomline blot result was reactive.The customer's non-reactive result with elecsys toxo igm was reproducible.The investigation determined the sample results are consistent with a recent infection with toxoplasma gondii, which was captured by elecsys toxo igg but not by elecsys toxo igm with the provided sample.Product labeling states: "a negative toxo igm test result, also in combination with a positive toxo igg result, does not completely rule out the possibility of an acute infection with toxoplasma gondii", since "in some individuals toxoplasma igm-specific antibodies may revert to non-reactive levels within few weeks after infection with t.Gondii".The investigation did not identify a product problem.

• Brand Name: ELECSYS TOXO IGM
• Common Device Name: ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21993034
• Report Number: 1823260-2025-01431
• Device Sequence Number: 4263669
• Product Code: LGD
• UDI-Device Identifier: 04015630940318
• UDI-Public: 04015630940318
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K162678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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: 08/31/2025
• Device Catalogue Number: 07028024190
• Device Lot Number: 824690
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Female