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

Catalog Number 06S61-22

Device Problems False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 04/07/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Was this device serviced by a third party? no.This report is being filed on an international product, list number 06s61-22 that has a similar product distributed in the us, list number 06s61-20.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported false negative alintiy i sars-cov-2 igg ii for a laboratory staff member that received the first dose of the astrazenica covid vaccine on (b)(6) 2021.The following data was provided (reference range: < 50.0 au/ml = negative, >/= 50.0 au/ml = positive): (b)(6).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.The customer does not know which results are correct therefore updated to document the results are discrepant and not false negative.Updated the (b)(4) to reflect the update to the patient results as being discrepant and not false negative.

Event Description

The customer reported discrepant alinity i sars-cov-2 igg ii quant.For a laboratory staff member that received the first dose of the astrazeneca covid vaccine on (b)(6) 2021.The following data was provided (reference range: < 50.0 au/ml = negative, >/= 50.0 au/ml = positive): 1st result on (b)(6) 2021: 5801.7 au / ml, repeated from another tube = 4314 au/ml, 2nd result on (b)(6) 2021 collected on (b)(6) 2021 same frozen tube: 17.1 au/ml, 3rd result (b)(6) 2021 from another tube collected on (b)(6) 2021: 15.6 au/ml, 4th result (b)(6) 2021 collected on (b)(6) 2021: 187.0 au/ml, 5th result (b)(6) 2021 collected on (b)(6) 2021: 190.0 au/ml, 6th result (b)(6) 2021 collected on (b)(6) 2021: 191.0 au/ml, 7th result (b)(6) 2021 taken on (b)(6) 2021: 192.0 au / ml.It is unknown to the customer which results are correct.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation 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.Sensitivity and specificity testing were done using an in-house retained kit of lot 25346fn00 stored at the recommended storage condition.All validity and acceptance criteria were met indicating that the lot is performing acceptably.Device history record review on lot 25346fn00 did not show any non-conformances or deviations associated with the customer¿s observation.Labeling was reviewed and found to adequately address the issue under review.The customer obtained discrepant/erratic results for one staff member who received the first dose of the astrazeneca covid vaccine on (b)(6) 2021 when testing was performed with alinity sars-cov-2 igg ii quant, lot 25346fn00.Positive and negative results were obtained for the initial sample collected from the patient.Erratic results were returned for the initial sample; 5801.7, 4314, 17.1 and 15.6 au/ml another sample draw returned consistent positive results of 187.0, 190.0, 191.0 and 192.0 au/ml.The customer is not sure if the patient should be returning positive or negative results.It was reported that the tubes were run without a barcode/manual programming.In this case sample integrity issues with the initial sample draw could have contributed to the customer¿s observation of discrepant/erratic results.Details around reagent and specimen handling are outlined in the product package insert, while the alinity ci-series operation manual also provides information regarding further potential causes of erratic results.Per the clinical performance section of the package insert, assay sensitivity (ppa) at = 15 days post-symptom onset is 99.35% (95 % ci 96.44, 99.97) and when immunocompromised patients were included, the ppa at = 15 days post-symptom onset was 97.01% (95% ci: 93.18, 98.71).The assay specificity (npa) is 99.60% (95% ci 99.22, 99.80).Results should be used in conjunction with other data; e.G., symptoms, results of other tests, and clinical impressions.Based on the investigation, no systemic issue or deficiency of the alinity sars-cov-2 igg ii quant reagent lot 25346fn00 was identified.This follow up is being submitted to include information previously submitted.

• 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: 11686615
• MDR Text Key: 280955690
• Report Number: 3008344661-2021-00091
• 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,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2021
• Device Catalogue Number: 06S61-22
• Device Lot Number: 25346FN00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(4); ALNTY I PROCESSING MODU, 03R65-01, (B)(4); ALNTY I PROCESSING MODU, 03R65-01, (B)(4)