MAUDE Adverse Event Report: ABBOTT IRELAND SARS-COV-2 IGM

Catalog Number 06R87-22

Device Problem False Positive Result (1227)

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

Event Date 06/11/2021

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: sid (b)(6).All available patient information is included.Additional patient details are not available.This report is being filed on an international product, list number 06r87-22 (sars-cov-2 igm) that has a similar product distributed in the us, list number 06r87-20 (advisedx sars-cov-2 igm), (b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer stated that (b)(6) was investigating a case at their site of a false positive architect sars-cov-2 igm result for a patient that presented no history of covid-19 or receiving the vaccine.The same patient went to another lab to be tested for sars-cov-2 igm and generated a negative result a few days later.The following data was provided (architect sars-cov-2 igm reference range: < 1.00 index is negative, >/= 1.00 index is positive): on (b)(6) 2021 sid (b)(6) = architect sars cov-2 igm result = 2.44 index (positive).The customer refused to provide any further information on the details of the second set of results from the other laboratory.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for false positive architect sars-cov-2 igm 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.Clinical sensitivity and specificity testing were done using an in-house retained kit of lot 27114fn00 stored at the recommended storage conditions.All validity and acceptance criteria were met indicating that the lot is performing acceptably.Device history record was reviewed and determined no non-conformances or deviations were identified.Labeling was reviewed and adequately addresses the issue under review.Results should be used in conjunction with other data; e.G., symptoms, results of other tests, and clinical impressions.Results from antibody testing should not be used as the sole basis to diagnose or exclude sars-cov-2 infection or to inform infection status.In this case, the patient did not present with any specific symptoms and no specific patient history or information on the other results from the other laboratory was provided.As the patient sample is not available no additional testing could be performed to further clarify the clinical status.Per summary and explanation section of the architect sars-cov-2 igm package insert, the host immune system reacts to the infection by sars-cov-2 by producing specific antibodies.These antibodies have been reported to appear in serum or plasma of infected individuals after the detection of viral ribonucleic acid (rna) in swabs and a few days to 2 weeks after the onset of symptoms.Specific igm antibodies to sars-cov-2 may be detectable in covid-19 patients during the symptomatic phase of the disease after rna is no longer detectable.At this time, duration and strength of the igm antibody response continue to be characterized; the kinetics of this response are unknown.Per the clinical performance section of the package insert, a study was performed to estimate the negative percent agreement (npa), 2965 serum and plasma specimens from subjects assumed to be negative for sars-cov-2 were tested using the sars-cov-2 igm assay.All of the specimens were collected prior to september 2019 (pre-covid-19 outbreak).The npa is 99.56% (95% ci: 99.25, 99.74).A study was also performed to estimate the positive percent agreement (ppa), between the sars-cov-2 igm assay and the polymerase chain reaction (pcr) comparator, 326 serum and plasma specimens were collected at different times from 103 subjects who tested positive for sars-cov-2 by a pcr method and who also presented with covid-19 symptoms.Each specimen was tested using the sars-cov 2 igm assay.The ppa and the 95% confidence interval (ci) were calculated.The ppa at = 31 days post-positive pcr result is 100.00% (95% ci: 51.01, 100.00).Twenty-eight (28) specimens from 8 immunocompromised patient were excluded from the study.When the results from these specimens were included, the ppa at = 31 days post-positive pcr result was 80.00% (95% ci: 37.55, 98.97).It should be noted that the duration of the igm antibody response has not been fully characterized.These study results are representative performance data.Results obtained in individual laboratories may vary.Based on the investigation architect sars-cov-2 igm reagent lot 27114fn00 is performing as intended, no systemic issue or deficiency of the architect sars-cov-2 igm reagent was identified.

• Brand Name: SARS-COV-2 IGM
• Type of Device: SARS-COV-2 IGM
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• MDR Report Key: 12443414
• MDR Text Key: 270485714
• Report Number: 3008344661-2021-00165
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2021
• Device Catalogue Number: 06R87-22
• Device Lot Number: 27114FN00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6); ARC I2000SR INST, 03M74-02, (B)(6)