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

Model Number TOXO IGM

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter questioned a negative elecsys toxo igm immunoassay result on a cobas 8000 e 801 module.The customer provided questioned results for one patient.The initial result was not reported outside the laboratory.The customer sent the sample to another facility for repeat testing on different analyzers, biomerieux and diasorin.The e 801 serial number is (b)(4).

Manufacturer Narrative

Additional information was requested but was not provided.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS TOXO IGM
• Type of Device: ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9841677
• MDR Text Key: 219395048
• Report Number: 1823260-2020-00753
• Device Sequence Number: 1
• Product Code: LGD
• Combination Product (y/n): N
• PMA/PMN Number: K162678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TOXO IGM
• Device Catalogue Number: 07028024190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 21 YR