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

Catalog Number 06R91-22

Device Problem False Positive Result (1227)

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

Event Date 06/21/2021

Event Type  malfunction  

Manufacturer Narrative

No further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed false positive sars-cov-2 igm results generated on the alinity i processing module for multiple samples (reference range: >/= 1.00 index (s/c) is positive).No specific patient information or data or comparison data was provided.No impact to patient management was reported.

Manufacturer Narrative

This report is being filed on an international product, list number 6r91-22 (sars-cov-2 igm) and has a similar product distributed in the us, list number 6r91-20/-30 (advisedx sars-cov-2 igm: eua # (b)(4)).The complaint investigation for false positive sars-cov-2 igm results included a search for similar complaints, and the review of complaint text, trending data, labeling, device history records, and in-house testing with a retained kit of lot 27096fn00.Return testing was not completed as returns were not available.Labelling was reviewed and found to adequately address the customer¿s issue.Device history record review on lot 27096fn00 did not show any potential non-conformances, or deviations associated with the customer¿s observation.In-house specificity and sensitivity testing was performed using an in-house retain kit of lot 27096fn00.All specifications were met indicating the lot is performing acceptably.The customer observed false positive sars-cov-2 igm results for multiple samples while using lot 27096fn00.Result data was not provided.It is unknown if these patients were vaccinated.Per the summary and explanation of test section in the 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).2985 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%.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.Based on the investigation sars-cov-2 igm reagent lot 27096fn00 is performing as intended, no systemic issue or deficiency 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: 12083616
• MDR Text Key: 258946757
• Report Number: 3008344661-2021-00131
• 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: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2021
• Device Catalogue Number: 06R91-22
• Device Lot Number: 27096FN00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, AI20596