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 03/28/2021

Event Type  malfunction  

Manufacturer Narrative

Added patient information for patient identifier, age at time of event, age units (patient), gender: id (b)(6), ((b)(6) year old female); id (b)(6), ((b)(6) year old female); id (b)(6), ((b)(6) year old male); id (b)(6), ((b)(6) year old male); id (b)(6), ((b)(6) year old male).All available patient information is included.Additional patient details are not available.Reporter postal code: a leading zero was added to the field because the system requires a minimum of 5 digits in the postal code field.This report is being filed on an international product, list number 6r87-22 that has a similar product distributed in the us, list number 6r87-20/-30.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed false positive architect sars-cov-2 igm results for 5 patients.The following data was provided (reference range sars-cov-2 igm: < 1.00 index = negative, >/= 1.00 index = positive): female patient (b)(6) years old, sample id (b)(6) - initial sars-cov-2 igm result = 1.41 index (tested on (b)(6) 2021), second result sid (b)(6) ¿ sars-cov-2 igm = 1.62 index; sars-cov-2 igg ii quant.First result = 0.8 au/ml (tested on (b)(6) 2021), third result sid (b)(6) ¿ sars-cov-2 igm = 1.24 index; sars-cov-2 igg ii quant.Second result = 0.1 au/ml (tested on (b)(6) 2021); pcr result = negative (tested on (b)(6) 2021).Female patient (b)(6) years old, sample id (b)(6) ¿ initial sars-cov-2 igm result = 1.38 index (tested on (b)(6) 2021), second result sid (b)(6) ¿ sars cov-2 igm = 1.50 index; sars-cov-2 igg ii quant.First result = 2.2 au/ml (tested on (b)(6) 2021); pcr result = negative (tested on (b)(6) 2021).Male patient (b)(6) years old, sample id (b)(6) ¿ initial sars-cov-2 igm result = 1.98 index, (tested on (b)(6) 2021), second result sid (b)(6) ¿ sars-cov-2 igm = 2.07 index; sars-cov-2 igg ii quant.First result = 1.4 au/ml (tested on (b)(6) 2021), third result sid (b)(6) -sars-cov-2 igm = 1.82 index; sars-cov-2 igg ii quant.Second result = 4.3 au/ml (tested on (b)(6) 2021); pcr result = negative (tested on (b)(6) 2021).Male patient (b)(6) years old, sample id (b)(6) - initial sars-cov-2 igm result = 2.04 index; sars-cov-2 igg ii quant.First result = 0.0 au/ml (tested on (b)(6) 2021), second result sid (b)(6) ¿ sars-cov-2 igm = 1.64 index; sars-cov igg ii quant.Second result = 0.0 au/ml (tested on (b)(6) 2021); pcr result = negative (tested on (b)(6) 2021).Male patient (b)(6) years old, sample id (b)(6) ¿ initial sars-cov-2 igm result 2.89 index; sars-cov2 igg ii quant.First result = 0.0 au/ml (tested on (b)(6) 2021), second result sid (b)(6) ¿ sars cov-2 igm = 2.73 index (tested on (b)(6) 2021), third result sid (b)(6) ¿ sars-cov-2 igm = 2.57 index; sars-cov-2 igg ii quant.Second result = 1.2 au/ml (tested on (b)(6) 2021); pcr result = negative (tested on (b)(6) 2021).The 5 patients have not been vaccinated and all the patients had a negative rheumatoid factor.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for falsely 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 requested due to the incorrect storage condition of the patient samples at the customers laboratory.Sensitivity and specificity testing were done using an in-house retained kit of lots 25043fn00 and 27114fn00 stored at the recommended storage conditions.All validity and acceptance criteria were met indicating that the lots are performing acceptably.Device history record review on lots 25043fn00 and 27114fn00 did not show any non-conformances, or deviations relating to the customer's issue.Labeling was reviewed and found to adequately address the issue under review.Per igm product labeling, 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.Positive igm results over one to two months with negative igg ii results could indicate potential false positive igm results or potential seroconversion with a delayed immune response for igg however further information would be required.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, no systemic issue or deficiency of the architect sars-cov-2 igm reagent, lots 25043fn00 and 27114fn00 were 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: 12014204
• MDR Text Key: 262078488
• Report Number: 3008344661-2021-00123
• 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: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• 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: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC COV2 IGM 100T OUS, 06R87-22, 25043FN00; ARC COV2 IGM 100T OUS, 06R87-22, 25043FN00; ARC I1000SR MOD, 01L86-01, I1SR56544; ARC I1000SR MOD, 01L86-01, I1SR56544