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

Catalog Number	07028024190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas 8000 e 801 is (b)(6).The patient samples were requested for investigation.The investigation reviewed the calibration data.The results were within specifications.The investigation reviewed the qc data.The results were within specifications.However, the exact days of measurement were unknown.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys toxo igm (toxo igm) results from 27 patient samples tested on the cobas 8000 e 801.The reporter stated that they observed an increased number of low-positive results.They then compared the results with another unknown methodology.The reporter was able to provide 14 patient samples with discrepant results.Please refer to the attachment (b)(4) for these results.
Additional Manufacturer Narrative
The patient samples were received for investigation.The investigation tested the patient samples for elecsys toxo igm using the reported reagent lot number.The investigation was able to confirm the customer¿s reactive/borderline toxo igm results for patient samples (b)(6).The investigation was able to confirm the customer¿s borderline toxo igm results for patient sample (b)(6).The investigation obtained non-reactive toxo igm results for patient samples (b)(6).The investigation was not able to confirm the customer¿s reactive/borderline toxo igm results.The patient samples were tested for the presence of interference.The investigation determined that patient sample (b)(6) was likely a false borderline reactive elecsys toxo igm result due to an unknown interference.The investigation determined the elecsys toxo igm results of patient samples (b)(6) were correct and were likely due to persistent toxo igm present in the sample.The investigation did not identify a product problem.

• Brand Name: ELECSYS TOXO IGM
• 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: 18301691
• Report Number: 1823260-2023-03923
• Device Sequence Number: 7152560
• Product Code: LGD
• UDI-Device Identifier: 04015630940318
• UDI-Public: 04015630940318
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• PMA/510(K) Number: K162678
• 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): 03/26/2024

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: 07/31/2024
• Device Catalogue Number: 07028024190
• Device Lot Number: 74065701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 03/26/2024
• 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: Unknown