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

Catalog Number 06S60-23

Device Problem False Positive Result (1227)

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

Event Date 09/12/2021

Event Type  malfunction  

Event Description

The customer observed a false positive sars-cov-2 igg ii quant result for one patient.The following data was provided (<50.0 au/ml is negative, >/=50.0 au/ml is positive): initial result, on (b)(6) 2021, was 68.8, repeated on (b)(6) 2021 was 13.6 au/ml.The patient was redrawn on (b)(6) 2021 and the results were 5.1 and 7.4 au/ml.Additional laboratory results for sars-cov-2 igm were provided: 0.08, 0.09, 0.07, and 0.09 index (s/c).There was no impact to patient management reported.

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.(b)(6).This report is being filed on an international product, list number 06s60-23 (sars-cov-2 igg ii quant) that has a similar product distributed in the us, list number 06s60-20 (advisedx sars-cov-2 igg ii), (b)(4).

Manufacturer Narrative

The complaint investigation for false positive architect sars-cov-2 igg ii quant 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 28453fn00, stored at the recommended storage conditions.All validity and acceptance criteria were met indicating that the lot is performing acceptably.Device history record review on lot 28453fn00 did not show any potential non-conformances or deviations.Labeling was reviewed and found to adequately address the issue under review.The customer reported a positive result (68.8 au/ml) for one patient sample when testing was performed with architect sars-cov-2 igg ii quant, lot 28453fn00.A negative igg ii result of 13.6 au/ml was obtained when the same sample was retested.Another sample was also collected from the patient with negative igg ii results of 5.1 and 7.4 au/ml returned.The patient was assessed as positive by pcr; however, no pcr test date was provided.The patient was also tested for igm with negative results obtained.To assess the specificity performance of the assay, a (b)(6) study was performed using frozen serum and plasma specimens from 2008 unique study subjects were tested using the sars-cov-2 igg ii quant assay.All specimens were collected prior to (b)(6) 2019 (pre-covid-19 outbreak) and were therefore assumed to be negative.The (b)(6) is 99.55% (95% ci 99.15, 99.76).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 igg ii quant reagent, lot number 28453fn00, was identified.

• 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
• MDR Report Key: 12563366
• MDR Text Key: 281339886
• Report Number: 3008344661-2021-00178
• 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: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2021
• Device Catalogue Number: 06S60-23
• Device Lot Number: 28453FN00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, (B)(4); ARC I2K PROC MOD, 03M74-01, (B)(4)