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

Catalog Number	04618858190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number of the customer's cobas e411 rack is 8979-23.The patient sample was received for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys toxo igm (toxo igm) results from one patient sample tested on the cobas e411 rack.The initial result was reported to the patient.The patient requested confirmation of the result and a new sample was collected.The new patient sample was also sent out to a reference laboratory for confirmation and was analyzed using the microparticle chemiluminescence laboratory method.On (b)(6) 2023: the initial result of the initial sample in the primary tube from the analyzer was "reactive" with a cut-off index (coi) of 1.4.On (b)(6) 2023: the repeat result of the new sample in a secondary tube from the analyzer was "reactive" with a coi of 1.21.On (b)(6) 2023: the repeat result of the aliquoted new sample from the reference laboratory was "non-reactive" with a coi of 0.08.On (b)(6) 2023: the repeat result of the initial sample in a sample cup from the analyzer was "reactive" with a coi of 1.38.The repeat result of the new sample in a sample cup from the analyzer was "reactive" with a coi of 1.18.
Additional Manufacturer Narrative
The investigation reviewed the last calibration performed on (b)(6) 2023.The signals were within the expected ranges.The investigation reviewed the qc recoveries for levels 1 and 2 on both measurement days; the qc recoveries were within the specified ranges.The investigation reviewed the customer's handling of patient samples; no issues were noted.Two patient samples were received for investigation.The investigation was able to reproduce the reactive results using the reported reagent lot.Non-reactive results were obtained for both patient samples when a newer reagent lot of the assay was used.This reagent lot has an improved specificity compared to the reported reagent lot.The result of the elecsys toxo igg assay for both patient samples was non-reactive.A previous exposure to toxoplasma gondii is unlikely and no immunological protection against a toxoplasma gondii infection should be assumed for the patient.An extensive investigation has confirmed a lower specificity for reagent lot 671956 (same production event as for lot 671949) compared to the previous lot 652164, showing an increase of approx.1.2 % in the amount of reactive elecsys toxo igm results.The investigations have confirmed a decreased specificity for this reagent lot but the reagent performs within specification.
Additional Manufacturer Narrative
In mfg report no 1823260-2023-02583, the 5th line should have been: "on 13-jul-2023: the repeat result of the aliquoted new sample from the reference laboratory was "non-reactive" with a coi of 0.08." instead of: "on 14-jul-2023: the repeat result of the aliquoted new sample from the reference laboratory was "non-reactive" with a coi of 0.08." b3 date of event was updated.D4 expiration date was updated.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17502966
• Report Number: 1823260-2023-02583
• Device Sequence Number: 19416200
• Product Code: LGD
• UDI-Device Identifier: 04015630921485
• UDI-Public: 04015630921485
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• 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,Followup
• Report Date (Section B): 11/27/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 04618858190
• Device Lot Number: 67194900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 09/13/2023; 11/02/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 10/06/2023; 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MEDICATIONS ASSOCIATED WITH PREGNANCY.
• Patient Age: 30 YR
• Patient Sex: Female