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	03/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample from the patient was provided for an investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys toxo igg results for one patient tested on a cobas 8000 e 801 module serial number (b)(4).On (b)(6) 2022, the patient's elecsys toxo igg results were reported outside the laboratory.The customer questioned the elecsys toxo igg results and the sample was tested on an abbott alinity analyzer and by western blot.The patient had an additional sample collected on (b)(6) 2022 for testing with the elecsys toxo igg reagent on an e 801 module and by western blot.
Additional Manufacturer Narrative
Below are the results of the investigation: the elecsys toxo igg result was 55.5 iu/ml reactive.The sample was neutralizable with 10.8 % of the remaining titer.The recomline blot toxo igg was positive.The elecsys toxo igg avidity result was 82 % avidity, high avidity.The elecsys toxo igm result was 0.264 coi non-reactive.The investigation reproduced the customer's elecsys toxo igg results, reactive.The investigation determined the elecsys toxo igg reactive result was correct.The patient's sample was non-reactive for anti-toxo igm and toxo igg was of high avidity.Thus, an acute infection of the patient was unlikely and a remote state of infection was concluded.The investigation did not identify a product problem.

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14712449
• Report Number: 1823260-2022-01751
• Device Sequence Number: 5233420
• Product Code: LGD
• UDI-Device Identifier: 04015630940301
• UDI-Public: 04015630940301
• Combination Product (Y/N): N
• 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): 07/29/2022

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: 12/31/2022
• Device Catalogue Number: 07028008190
• Device Lot Number: 59823401
• 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: 05/24/2022
• Supplement Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 07/29/2022
• 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