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

Catalog Number	07028008190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys toxo igg, elecsys anti-hbc ii, and elecsys hbsag gen.2 immunoassay results from three patient samples tested on the cobas e 801 analytical unit (with 3 modules: module a, module b, and module c).The questionable results were found while the reporter was performing an instrument validation.This medwatch is for the elecsys toxo igg assay.Please refer to the medwatch with: a1.Patient identifier (b)(6) for the elecsys hbsag ii assay.A1.Patient identifier (b)(6) for the elecsys anti-hbc ii assay.Sample (b)(6): on (b)(6) 2024, the initial toxo igg result from module a was 0.180 iu/ml with a data flag.On (b)(6) 2024, the repeat result from module b was 14.6 iu/ml.Sample (b)(6): on (b)(6) 2024, the initial toxo igg result from module c was 2.17 iu/ml.The first repeat result from module b was 2.10 iu/ml.On (b)(6) 2024, the second repeat result from module b was 13.5 or 13.05 iu/ml.The reporter stated that the repeat results might be the correct results.
Additional Manufacturer Narrative
The serial number of the cobas e 801 analytical unit is (b)(6).The investigation reviewed the calibration data.Module a and c's 29-jul-2024 calibrations were within specifications but with a low calibrator 2 signals.Module b's 29-jul-2024 calibration was within specifications.Module c's 29-jul-2024 calibration was within specifications but with a low calibrator 2 signals.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation reviewed the toxo igg calibration for module a, module b, and module c and the results were within specifications; module a and module c had low calibration 2 signals.The investigation reviewed the qc for all modules and the results were within specifications.The alarm trace and data showed multiple sample quality-related alarms.The investigation determined the event was consistent with a preanalytic issue at the customer site (sample quality).Preanalytics are within the customer's responsibility.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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 20304359
• Report Number: 1823260-2024-02763
• Device Sequence Number: 7588433
• Product Code: LGD
• UDI-Device Identifier: 04015630940301
• UDI-Public: 04015630940301
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• 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): 10/18/2024

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 Catalogue Number: 07028008190
• Device Lot Number: 787027
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/18/2024
• 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
• Patient Sex: Unknown