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	04/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned positive results for 1 patient sample tested for elecsys toxo igg (toxo igg) on a cobas e 801 analytical unit.On (b)(6) 2023 the patient had a toxo igg result from the e801 analyzer of < 1 iu/ml (negative).The toxo igm result was 0.22 coi (negative).On (b)(6) 2023 a new sample was obtained and the toxo igg result from the e801 analyzer was 20 iu/ml (positive).The toxo igm result was 0.24 coi (negative).Due to the difference between the 2 samples for toxo igg, both samples were repeated and the results from each sample were reproducible: the toxo igg result from the sample obtained on (b)(6) 2023 was negative.The toxo igg result from the sample obtained on (b)(6) 2023 was 20 iu/ml (positive).The questionable results were reported outside of the laboratory.Due to suspicions of a recent infection, the doctor requested repeat testing.The sample was sent to an external laboratory where the toxo igg result from the roche method was 19.44 iu/ml (positive).The toxoplasma igg avidity result was high.As the avidity result did not correspond to a recent infection, the sample from (b)(6) 2023 was sent to a reference laboratory: the toxoplasmosis igg result from the enzyme linked fluorescent assay (elfa) was negative.The toxoplasmosis igg result from the enzyme-linked immunosorbent assay (elisa) was negative.The customer suspects an interference for the sample obtained on (b)(6) 2023.The e801 module serial number was (b)(6).
Additional Manufacturer Narrative
The sample was requested for investigation, but was not available.Calibration signals from (b)(6) 2023 were within specified ranges.Quality controls recovered within expected ranges.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17064880
• Report Number: 1823260-2023-01848
• Device Sequence Number: 12456521
• Product Code: LGD
• UDI-Device Identifier: 04015630940301
• UDI-Public: 04015630940301
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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
• Report Date (Section B): 06/05/2023

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: 08/31/2023
• Device Catalogue Number: 07028008190
• Device Lot Number: 657892
• 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: 05/16/2023
• Initial Report FDA Received Date: 06/05/2023
• 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
• Patient Age: 34 YR
• Patient Sex: Female