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	07/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys toxo igg on a cobas 8000 e 801 module.A questionable result from the sample was reported outside of the laboratory to a medic, who requested a rerun.The sample initially resulted in a toxo igg value of 11.5 iu/ml (reactive) on the e 801 analyzer.The sample was repeated on the e 801 analyzer on (b)(6) 2022, resulting in a value of 12.1 iu/ml (reactive).The sample was sent to two other laboratories for testing on the vidas and alinity platforms.It is not known specifically which platform was used at each laboratory.At the first laboratory, the toxo igg result was < 1 iu/ml (negative) on (b)(6) 2022.At the second laboratory, the toxo igg result was 0.40 iu/ml (negative) on (b)(6) 2022.The e 801 analyzer serial number is (b)(4).
Additional Manufacturer Narrative
The last calibration performed on (b)(6) 2022 was within expected ranges.The investigation could not identify a product problem.The cause of the event could not be determined.A general reagent issue can be excluded.The patient sample was requested for investigation, but the remaining volume was too low.

• 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: 15405902
• Report Number: 1823260-2022-02807
• Device Sequence Number: 12172329
• Product Code: LGD
• UDI-Device Identifier: 04015630940301
• UDI-Public: 04015630940301
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 10/18/2022

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 Catalogue Number: 07028008190
• Device Lot Number: 598234
• 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: 08/23/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 10/18/2022
• 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: Unknown