MAUDE Adverse Event Report: DIASORIN S.P.A. LIAISON SARS-COV-2 S1/S2 IGM; QUALITATIVE DETECTION OF IGM ANTIBODIES TO SARS-COV-2

Catalog Number 311470

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Diasorin (b)(4) received a complaint from a customer concerning positive results obtained with the liaison sars-cov-2 igm assay (lot 360006-ce).Following cases were reported and analysed: patients of preventive medicine (health workers who had covid in (b)(6), confirmed by a positive molecular biology swab), followed by covid igg serological test, and also covid igm for about 20 days.Seven (7) out of thirty (30) workers, who had no symptoms but a covid history, resulted positive with igm index values of 5-6.Swabs in molecular biology were performed and resulted negative.Cases of positive swab patients in (b)(6), with igg currently positive (seroconversion), but with positive igm values after 9 months.Screening tests of patients who needed to be hospitalized and subjected to rapid swab, igm and igg serological tests.They had no symptoms; the rapid swab gave a negative result, the igg were negative, but the igm were positive with index values equal to 2.8-3.The same patients were immediately tested with a swab in molecular biology, confirming the negative result.Since the covid igm result was positive, the customer was having problems in the management of the patients at the hospital level.Based on the data provided, a total of 523 samples were tested during the period analysed (august 3rd, 2020 - november 19th, 2020) with the liaison sars-cov-2 igm assay (lot 360006) on liaison xl (s/n (b)(4)): 466 samples were graded negative and 57 samples positive.There were a few events of "tips pick up failed" during the period analyzed.Before retest, no pre-analytical step was performed.The analysis of the pressure profiles did not highlight any anomaly (either in aspiration or dispensation).Thirteen (13) weekly and three (3) monthly maintenance activities were tracked as succeeded in the investigated period, but in two cases a delay was observed: the monthly maintenance task on september 26th, 2020 was performed with a delay of 3 days, the weekly maintenance task on november 12th, 2020 with a delay of 9 days.In addition, during the investigated period, the cleaning tool accessory was not always used as prescribed and kits with obs expired were used to test specimens.Based on the data analysis and information received, the complaint was classified as not confirmable.No clear root cause could be identified, however the issue could be sample related or linked to inaccurate reagent handling or to inaccurate instrument maintenance.Release batch sheet and nc database were reviewed without highlighting anomalies.

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 (b)(4) received a complaint from a customer concerning positive results obtained with the liaison sars-cov-2 igm assay.

• Brand Name: LIAISON SARS-COV-2 S1/S2 IGM
• Type of Device: QUALITATIVE DETECTION OF IGM ANTIBODIES TO SARS-COV-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: 11989154
• MDR Text Key: 259189070
• Report Number: 9610240-2021-00037
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 311470
• Device Lot Number: 360006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1