MAUDE Adverse Event Report: ABBOTT IRELAND SARS-COV-2 IGG

Catalog Number 06R90-22

Device Problem False Negative Result (1225)

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

Event Date 09/24/2021

Event Type  malfunction  

Event Description

The customer observed false negative alinity i sars-cov-2 igg results for several patients since using a new sars-cov-2 igg reagent lot 33057ud00.The customer reran some patient samples that previously generated a positive result, however when tested using the new reagent lot are generating a negative result.There is no specific patient data or patient information provided by the customer.There was no impact to patient management reported.

Manufacturer Narrative

This report is being filed on an international product, list number 06r90-22 (sars-cov-2 igg) that has a similar product distributed in the us, list number 06r90-20 /-30 (sars-cov-2 igg), (b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The complaint investigation for falsely negative alinity i sars-cov-2 igg 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 available.The ticket search determined normal complaint activity for the likely cause lot.Trending review determined no trends identified for the product for the issue.Clinical sensitivity and specificity testing was completed with an in-house retained kit of the complaint lot 33057ud00.All specifications were met indicating the lots are performing acceptably.Device history record was reviewed and did not identify any non-conformances or deviations.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency for alinity i sars-cov-2 igg reagent lot 33057ud00 was identified.

• Brand Name: SARS-COV-2 IGG
• Type of Device: SARS-COV-2 IGG
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12586528
• MDR Text Key: 283477413
• Report Number: 3008344661-2021-00182
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2022
• Device Catalogue Number: 06R90-22
• Device Lot Number: 33057UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2021
• Is the Device Single Use?: No
• 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)