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

Catalog Number 06S60-32

Device Problem False Positive Result (1227)

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

Event Date 11/03/2021

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, list number 06s60-32 (sars-cov-2 igg ii quant) that has a similar product distributed in the us, list number 06s60-30 (advisedx sars-cov-2 igg ii), (b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported a false positive architect sars-cov-2 igg ii quant result for a patient.The following data was provided: on (b)(6) 2021, sid (b)(6) = sars-cov-2 igg ii quant result = 15448.7 au/ml (positive) the patient had covid because the pcr testing generated a positive result.However, the patient did not have a history of not producing covid igg antibodies.The laboratory thawed the stored frozen sample from (b)(6) 2021 and repeated the testing with sid (b)(6) and generated a result of 25 au/ml (negative) correlating to the patient¿s history.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for false positive architect sars-cov-2 igg ii quant results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.The lot search review did not identify an increase in complaint activity for the issue for the lot.Trending was reviewed and did not identify any trends for the product for the issue.Clinical specificity and sensitivity testing was performed using an in-house retained kit of lot 31202fn00.All specifications were met indicating the lot is performing acceptably.In this case, discrepant results were obtained.The reason for the discrepant results is unclear however sample integrity issues or instrumentation issues at the time of testing could have contributed to the customer¿s observation.Details around reagent and specimen handling are outlined in the product package insert, while the architect system operations manual also provides information regarding further potential causes of erratic results.The device history record was reviewed and did not identify any non-conformances or deviations for the lot number 31202fn00.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency for architect sars-cov-2 igg ii quant reagent lot 31202fn00 was identified.D8: was device serviced by third party? initial: unknown updated: no.

• Brand Name: SARS-COV-2 IGG II QUANT REAGENT KIT
• Type of Device: SARS-COV-2 LGG
• 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, IL N39 E-932 ; 2246682940
• MDR Report Key: 12953629
• MDR Text Key: 283256815
• Report Number: 3008344661-2021-00210
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2022
• Device Catalogue Number: 06S60-32
• Device Lot Number: 31202FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, ISR52058; ARC I2000SR INST, 03M74-02, ISR52058