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

Catalog Number	04618858190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas 6000 e601 module is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys toxo igm (toxo igm) results from one patient sample tested on the cobas 6000 e601 module.The patient sample was sent to two external laboratories: laboratory 1 and laboratory 2.On (b)(6) 2023, the initial result from the module was 4.81 cut-off index (coi) with an interpretation of "reactive".On (b)(6) 2023, the first repeat result from laboratory 1 was "index less than 0.10" (non-reactive).On (b)(6) 2023, the second repeat result from the module was 4.96 coi with an interpretation of "reactive".On (b)(6) 2023, the third repeat result from laboratory 2 was "0.00 index - negative".
Additional Manufacturer Narrative
The investigation reviewed the last calibration performed on 06-nov-2023; the signals were within the expected ranges.The investigation reviewed the qc recovery; the qc recovery overview for qc level 1 showed results that were within the specified ranges.The investigation determined the reagent performed within specifications.

• 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: 18306433
• Report Number: 1823260-2023-03939
• Device Sequence Number: 17838641
• Product Code: LGD
• UDI-Device Identifier: 04015630921485
• UDI-Public: 04015630921485
• Combination Product (Y/N): Y
• Initial Reporter Country: SP
• 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): 01/10/2024

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: 02/29/2024
• Device Catalogue Number: 04618858190
• Device Lot Number: 712929
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 12/28/2023
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 01/10/2024
• 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: Female