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	08/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's sample was returned for investigation.Product labeling states: "the elecsys toxo igg assay can be interpreted as follows: non-reactive: < 1 iu/ml, equivocal: = 1 - < 3 iu/ml, reactive: = 3 iu/ml." the investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys toxo igg results for 1 patient sample on a cobas e 801 analytical unit, serial number (b)(4).The toxo igg result was negative using the liaison xl diasorin method in a different laboratory.A numerical result was not provided.The elecsys toxo igg result was 66.5 iu/ml (reactive) on the e 801 module.It is unknown which result is believed to be correct.The results were reported outside of the laboratory.
Additional Manufacturer Narrative
Section d4, lot number and expiration date were updated.The patient sample was investigated.Investigation results: elecsys toxo igg: 67.0 iu/ml (reactive).Sample was neutralizable: 10.6 % of remaining titer.Recomline blot toxo igg: positive (weak p30-band).Elecsys toxo igg avidity: 91 avi-% (high avid).Elecsys toxo igm: 0.254 coi (non-reactive).The customer¿s results for the alleged patient sample with elecsys toxo igg assay were reproducible, therefore shown to be reactive.The investigation found the elecsys toxo igg result is reactive.The patient sample was non-reactive for anti-toxo igm and toxo igg was high-avidity.Thus, an acute infection of the patient is unlikely and a remote state of infection is assumed in this case.The reagent performed within specification.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 15382532
• Report Number: 1823260-2022-02760
• Device Sequence Number: 5821235
• 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): 10/05/2022

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: 598234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 10/05/2022
• 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