MAUDE Adverse Event Report: ABBOTT IRELAND SARS-COV-2 IGG II QUANT REAGENT KIT; REAGENT, CORONAVIRUS SEROLOGICAL

Catalog Number 06S60-23

Device Problem False Negative Result (1225)

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

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 6s60-23 (sars-cov-2 igg ii quant ) and has a similar product distributed in the us, list number 6s60-20/-30 (advisedx sars-cov-2 igg ii: eua#: (b)(4)).

Event Description

The customer observed a false negative sars-cov-2 igg ii quant result for a 40 year old male physician who was pcr positive on (b)(6) 2022.The following data was provided (reference range: results <50.0 au/ml is negative): (b)(6) 2022, sid (b)(6) initial result was 7.6 au/ml no impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for a false negative sars-cov-2 igg ii quant result included a search for similar complaints, and the review of complaint text, trending data, labelling, and device history records.Additionally, in-house performance testing for reagent lot 36532fn00 was completed.Return testing was not performed as returns were not available.Device history record review on lot 36532fn00 did not show any potential non-conformances, or deviations associated with the customer¿s observation.Labelling was reviewed and found to adequately address the issue under review.In-house performance testing for reagent lot 36532fn00 was completed using a retained sample of the complaint lot.All specifications were met indicating the lot is performing acceptably.The reason for the negative result is unclear.Per the limitations of the procedure section of the package insert, immunocompromised patients who have covid-19 may have a delayed antibody response and produce levels of antibody which may not be detected as positive by the assay.However, in this case it was reported that the patient had no underlying conditions that may have contributed to a poor immune response.Per product labeling, higher titer antibody responses have been observed in patients with more severe illness as compared with mildly symptomatic or asymptomatic individuals.Based on the investigation, no systemic issue or deficiency of the sars-cov-2 igg ii quant reagent lot 36532fn00 was identified.This report is being filed on an international product, list number 6s60-23 (sars-cov-2 igg ii quant ) and has a similar product distributed in the us, list number 6s60-20/-30 (advisedx sars-cov-2 igg ii: eua # 203119).

• Brand Name: SARS-COV-2 IGG II QUANT REAGENT KIT
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15451155
• MDR Text Key: 300652595
• Report Number: 3008344661-2022-00112
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2022
• Device Catalogue Number: 06S60-23
• Device Lot Number: 36532FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, ISR63712; ARC I2K PROC MOD, 03M74-01, ISR63712