MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TOXO IGG IMMUNOASSAY; 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	10/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable high elecsys toxo igg immunoassay results for one patient tested on a cobas 8000 e 801 module serial number (b)(4).The patient's elecsys toxo igg results were reported outside the laboratory.After a previous treatment with immunoglobulins, the patient's physician questioned the high toxo igg results from the sample collected on (b)(6) 2021.The customer performed repeat testing with the patient's sample.Also, the patient's sample was sent to two different laboratories for further testing.On (b)(6) 2021, the patient had a new sample collected.It was requested but not provided if the toxo igg result was questioned by the physician.Refer to the attachment on the medwatch for all patient data.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable high elecsys toxo igg immunoassay results for one patient tested on a cobas 8000 e 801 module serial number (b)(4).The patient's elecsys toxo igg results were reported outside the laboratory.After a previous treatment with immunoglobulins, the patient's physician questioned the high toxo igg results from the sample collected on (b)(6) 2021.The customer performed repeat testing with the patient's sample.Also, the patient's sample was sent to two different laboratories for further testing.On (b)(6) 2021, the patient had a new sample collected.It was requested but not provided if the toxo igg result was questioned by the physician.Refer to the attachment on the medwatch for all patient data.
Additional Manufacturer Narrative
Clarification was received for terms "anti-sm" and "fam" mentioned in supplemental report 1823260-2021-03404-01."anti-sm" stands for antibodies to the smith antigen and "fam" should be "fan" which stands for antinuclear factor.This test is used as a screening test for the presence of autoantibodies in cases of suspected autoimmune diseases.It was noted that the patient took several medications (immunoglobulins and gamma globulins) in high doses from different manufacturers while she was hospitalized.The specific medications were not provided.Section d4, expiration date was updated.Calibration signals from (b)(6)-2021 and (b)(6)2021 were within the expected ranges.The qc data provided from (b)(6), (b)(6) and (b)(6) 2021 were within the specified ranges.The investigation determined the event was consistent with the patient being administered a pharmaceutical drug containing immune globulins.The investigation did not identify a product problem.The cause of the event could not be determined.
Additional Manufacturer Narrative
The patient's toxo igg result from (b)(6)2021 was reported outside the laboratory.Updated medwatch fields: b6 - relevant test/laboratory data and b7 - other relevant history.

• Brand Name: ELECSYS TOXO IGG IMMUNOASSAY
• 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: 12843972
• Report Number: 1823260-2021-03404
• Device Sequence Number: 4205430
• Product Code: LGD
• UDI-Device Identifier: 04015630940301
• UDI-Public: 04015630940301
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K073501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/06/2022

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: 10/31/2021
• Device Catalogue Number: 07028008190
• Device Lot Number: 517479
• 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: 10/25/2021
• Supplement Date Received by Manufacturer: 11/23/2021; 12/30/2021
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 12/14/2021; 01/06/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: IMMUNOGLOBULIN
• Patient Age: 37 YR
• Patient Sex: Female