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

Catalog Number	07028008190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The samples were requested for investigation.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys toxo igg and cmv igg elecsys e2g results for 1 patient on a cobas 8000 e 801 module.The sample from (b)(6)2023 produced the following results: the cmv igg elecsys e2g result was <0.25 ui/ml (non-reactive).The cmv igm elecsys result was 0.12 coi (non-reactive).Another method (diasorin liaisonxl ) was used at a reference laboratory and the cmv igg result was <5.0 au/ml (negative).Another method (diasorin liaisonxl ) was used at a reference laboratory and the cmv igm result was <5.0 au/ml (negative).The sample from (b)(6) 2023 produced the following results: the elecsys toxo igg result was < 0.18 ui/ml (non-reactive).The elecsys toxo igm result was 0.16 coi (non-reactive).The cmv igg elecsys e2g result was <0.25 ui/ml (non-reactive).The cmv igm elecsys result was 0.12 coi (non-reactive).Another method (diasorin liaisonxl ) was used at a reference laboratory and the toxoplasma igg result was 0 ui/ml (negative).Another method (diasorin liaisonxl ) was used at a reference laboratory and the toxoplasma igm result was <3.00 index (negative).The westernblot toxo igg (ldbio diagnostics method) overall interpretation of the result was negative.The sample from (b)(6) 2024 produced the following results: the elecsys toxo igg result was 19.20 ui/ml (reactive).The elecsys toxo igm result was 0.19 coi (non-reactive).The cmv igg elecsys e2g result was 4.07 ui/ml (reactive).The cmv igm elecsys result was 0.15 coi (non-reactive).Another method (diasorin liaisonxl ) was used at a reference laboratory and the toxoplasma igg result was 0.186 ui/ml (negative).Another method (diasorin liaisonxl ) was used at a reference laboratory and the toxoplasma igm result was <3.00 index (negative).Another method (diasorin liaisonxl ) was used at a reference laboratory and the cmv igg result was <5.0 au/ml (negative).Another method (diasorin liaisonxl ) was used at a reference laboratory and the cmv igm result was <5.0 au/ml (negative).The westernblot toxo igg (ldbio diagnostics method) overall interpretation of the result was negative.This medwatch will apply to the elecsys toxo igg assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the cmv igg elecsys e2g assay.
Additional Manufacturer Narrative
Samples from the patient were submitted for investigation and the reactive elecsys toxo igg and cmv igg results were reproducible and considered correct.A passive transfer of anti-toxo igg and anti-cmv igg antibodies by the treatment with hyperimmunoglobulins is suspected.

• Brand Name: ELECSYS TOXO IGG
• 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: 18809483
• Report Number: 1823260-2024-00601
• Device Sequence Number: 20660663
• Product Code: LGD
• UDI-Device Identifier: 04015630940301
• UDI-Public: 04015630940301
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K073501
• 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): 04/08/2024

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: 09/30/2024
• Device Catalogue Number: 07028008190
• Device Lot Number: 70024501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 04/08/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VARITECT
• Patient Age: 44 YR
• Patient Sex: Female