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

Model Number	TOXO IGM
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: na.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the elecsys toxo igm immunoassay on a cobas 6000 e 601 module (serial number (b)(4).No incorrect results were reported outside of the laboratory.The sample initially resulted in a toxo igm value of 2.55 coi (reactive) when tested on the e 601 analyzer.The sample was repeated using the biomeriuex method and the result was negative.The sample was repeated on the e 601 analyzer on (b)(6) 2022, resulting in only a data flag indicating system reagent volume was short.The sample was repeated again on the e 601 analyzer on (b)(6) 2022, resulting in a value of 2.52 coi (reactive).On (b)(6) 2022, the sample was tested with an unknown competitor chemiluminescence assay, resulting in a negative toxo igm value.
Additional Manufacturer Narrative
A sample from the patient was provided for investigation and the result obtained by the customer could be reproduced.It was determined the sample contains an interfering factor against the ruthenium component of the elecsys toxo igm immunoassay.The sample is non-reactive for toxo igg.Per product labeling: "in rare cases, interference due to extremely high titers of antibodies to immunological components, streptavidin or ruthenium can occur.These effects are minimized by suitable test design." based on the specificity claim for the elecsys toxo igm immunoassay, single false positives can occur.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14735009
• Report Number: 1823260-2022-01769
• Device Sequence Number: 16697969
• Product Code: LGD
• UDI-Device Identifier: 04015630921485
• UDI-Public: 04015630921485
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 08/12/2022

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: 11/30/2022
• Device Model Number: TOXO IGM
• Device Catalogue Number: 04618858190
• Device Lot Number: 59034001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 08/12/2022
• 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
• Patient Sex: Female