MAUDE Adverse Event Report: DIASORIN S.P.A. LIAISON SARS-COV-2 IGM; SEROLOGICAL ASSAY FOR QUALITATIVE DETECTION OF IGM ANTOBIDIES TO SARS COVID 2

Catalog Number 311470

Device Problem False Positive Result (1227)

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

Event Type  malfunction  

Manufacturer Narrative

Initial notification, investigation on going.

Event Description

In light of the covid-19 pandemic and the subsequent authorizations (euas) for sars-cov-2 diagnostics tests and per the conditions of the emergency use authorization, suspected false negatives, false positives and significant changes in expected performance characteristics will be reported under 21 cfr 803.The alleged false test results in this event have not caused patient injury or death; however, this event is being reported conservatively because if the alleged malfunction were to recur there is a non-remote potential for serious injury or death.Diasorin s.P.A.Received a complaint from a customer reporting that a patient sample, which graded as positive on the diasorin assay, resulted as negative on caiptain clia platform assay.

• Brand Name: LIAISON SARS-COV-2 IGM
• Type of Device: SEROLOGICAL ASSAY FOR QUALITATIVE DETECTION OF IGM ANTOBIDIES TO SARS COVID 2
• Manufacturer (Section D): DIASORIN S.P.A.; via crescentino snc; saluggia, vercelli 13040 ; IT 13040
• Manufacturer (Section G): DIASORIN S.P.A.; via crescentino snc; saluggia, vercelli 13040 ; IT 13040
• Manufacturer Contact: barbara belluati ; via crescentino snc; saluggia, vercelli 13040 ; IT 13040
• MDR Report Key: 12139642
• MDR Text Key: 262953580
• Report Number: 9610240-2021-00041
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: TC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/25/2021
• Device Catalogue Number: 311470
• Device Lot Number: 360013
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1