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

Model Number TOXO IGG

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2022

Event Type  malfunction  

Manufacturer Narrative

Quality controls and calibration were acceptable.As no sample material was available, no further investigation was possible.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

There was an allegation of a questionable false positive toxo igg elecsys result from cobas e411 rack analyzer serial number (b)(4).The initial result was 33 iu/ml and the repeat result was 33.8 iu/ml.The same sample was measured in another three laboratories using non-roche instruments and the results were all-negative and near 0 (non-reactive)for both igg and igm.The questionable results were not reported outside of the laboratory.A negative result was reported for the patient.

• Brand Name: ELECSYS TOXO IGG
• Type of Device: 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: 15881844
• MDR Text Key: 307768425
• Report Number: 1823260-2022-03801
• Device Sequence Number: 1
• Product Code: LGD
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K073501
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TOXO IGG
• Device Catalogue Number: 04618815190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1