MAUDE Adverse Event Report: ABBOTT IRELAND ADVISEDX SARS-COV-2 IGM REAGENT KIT; SARS-COV-2 IGM CMIA FOR THE QUALITATIVE DET OF IGM AB TO SARS-COV-2

Model Number	06R8720
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint investigation for false positive advisedx sars-cov-2 igm results included a search for similar complaints, the review of complaint text, trending data, labeling, and device history records.Sensitivity and specificity testing was done using an in-house retained kit of lot number 21412fn00, stored at the recommended storage conditions.All validity and acceptance criteria were met indicating that the lot is performing acceptably.Return testing was not complete as return samples were not available.Device history record review on lot number 21412fn00 did not show any potential non-conformances or deviations.Labeling was reviewed and found to adequately address the issue under review.The customer observed a false positive result for one patient, while using advisedx sars-cov-2 igm reagent lot number 21412fn00.The patient was positive with sars-cov-2 igm testing but was negative when tested with sars-cov-2 igg testing.In this case, no specific patient history was provided.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 advisedxsars-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).Per summary and explanation section of the 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.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, advisedx sars-cov-2 igm, reagent lot number 21412fn00, is performing as intended, no systemic issue or deficiency of the reagent was identified.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed a false positive advisedx sars-cov-2 igm result for one patient, who hasn¿t been exposed to covid-19, on an architect i1000sr analyzer.The patient was positive with sars-cov-2 igm testing but was negative when tested with sars-cov-2 igg testing.There was no impact to patient management reported.

• Brand Name: ADVISEDX SARS-COV-2 IGM REAGENT KIT
• Common Device Name: SARS-COV-2 IGM CMIA FOR THE QUALITATIVE DET OF IGM AB TO SARS-COV-2
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• MDR Report Key: 11240348
• Report Number: 3008344661-2021-00028
• Device Sequence Number: 11655580
• Product Code: QKO
• UDI-Device Identifier: 00380740191863
• UDI-Public: 00380740191863
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 06R8720
• Device Catalogue Number: 06R87-20
• Device Lot Number: 21412FN00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1