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

Catalog Number 06S61-22

Device Problem False Positive Result (1227)

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

Event Date 06/03/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.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 /-30.

Event Description

The customer reported a false positive alinity i sars-cov-2 igg ii quant.Result for a patient while using the alinity i processing module.The following data was provided (reference range: < 50 au/ml is negative, >/= 50.0 au/ml is positive): on (b)(6) 2021 sid (b)(6), result 1 = 145.1 au/ml, result 2 = 0.9 au/ml; on (b)(6) 2021 result 3 = 0.0 auml there was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for a false positive alinity i sars-cov-2 igg ii quant.Result 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.In-house testing for reagent lot 26355fn00 was completed using a retained sample of the complaint lot 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 26355fn00 did not show any non-conformances, or deviations associated with the complaint.Labeling was reviewed and found to adequately address the issue under review.Labeling was reviewed and adequately addresses the issue under review.Repeat testing was performed on the sample with the same reagent kit and a different kit of the same reagent lot with negative results returned, indicating that the issue could potentially be related to sample integrity or instrumentation issues at the time of testing.Details around 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.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 26355fn00 was identified.This report is being filed on an international product, list number 06s61-22 (sars-cov-2 igg ii quant) that has a similar product distributed in the us, list number 06s61-20/-30 (advisedx sars-cov-2 igg ii), eua203119.

• 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: 12018237
• MDR Text Key: 256764535
• Report Number: 3008344661-2021-00125
• 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: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2021
• Device Catalogue Number: 06S61-22
• Device Lot Number: 26355FN00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, AI01983