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

Catalog Number 06S61-22

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 09/18/2021

Event Type  malfunction  

Manufacturer Narrative

Patient identifer: sid (b)(6).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 6s61-22 (sars-cov-2 igg ii quant) and has a similar product distributed in the us, list number 6s61-20/-30 (advisedx sars-cov-2 igg ii: eua # (b)(4).

Event Description

The customer observed imprecise sars-cov-2 igg ii quant results generated on the alinity i processing module for one sample.The following data was provided (reference range: >/= 50 au/ml is positive): first sample: sid (b)(6) initial result = 76.1 au/ml (cord blood serum).Sid (b)(6) initial result = 42 au/ml (cord blood heparin) no impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for imprecise sars-cov-2 igg ii quant results included a search for similar complaints, and the review of complaint text, trending data, labeling, scientific literature and device history records.Return testing was not completed as returns were not available.In-house sensitivity testing for reagent lot 30307fn00 was completed using a retained sample of the complaint lot.All specifications were met indicating the lot is performing acceptably.Device history record review on lot 30307fn00 did not show any nonconformances, potential nonconformances, or deviations associated with the complaint issue.Labeling was reviewed which adequately address the issue under review.Discrepant results were observed for one cord blood sample.Serum and plasma specimen types are verified for use with the alinity i sars-cov-2 igg ii quant assay.Specimens can be taken from venous blood samples and capillary blood samples.Cord blood samples are not documented in product labeling.Customer support advised the customer to use samples that are verified for use with the assay.Studies have also been completed that show equivalency between serum and plasma using the tube types listed in the sars-cov-2 igg ii package insert specimen collection and preparation for analysis, specimen types section.The studies performed demonstrated equivalency for matched serum and plasma edta results on the sars-cov-2 igg ii assay.Per the ticket notes, the customer does not know what date the samples were drawn and received the samples from another laboratory on the 18 sep 2021.The customer stored the samples at room temperature.Customer support informed the customer that the maximum storage time is 2 days for samples stored at room temperature.A within-laboratory precision study was conducted using 2 lots of the sars-cov 2 igg ii quant reagent kit, 2 lots of the sars-cov-2 igg ii quant calibrator kit, and 1 lot of the sars-cov-2 igg ii quant control kit and 1 alinity i instrument.Three controls and 3 human plasma panels were assayed in replicates of 3, at 2 separate times per day, on 20 different days, for a total of 120 replicates for each test sample.Data for the low panel, medium panel and positive control 2 were reviewed as the mean values are closest to the customers results for the two samples.The low panel with a mean (au/ml) value of 46.9 has a %cv of 3.2 for the within-run (repeatability) and a %cv of 5.6 for within-laboratory which includes within-run, between-run, and between-day variability.The medium panel with a mean (au/ml) value of 85.9 has a %cv of 2.3 for the within-run (repeatability) and a %cv of 4.1 for within-laboratory.The positive control 2 with a mean (au/ml) value of 603.1 has a %cv of 2.4 for the within-run (repeatability) and a %cv of 3.1 for within-laboratory.Based on the investigation sars-cov-2 igg ii quant reagent lot 30307fn00 is performing as intended, no systemic issue or deficiency of the sars-cov-2 igg ii quant reagent was identified.

Event Description

The customer observed imprecise sars-cov-2 igg ii quant results generated on the alinity i processing module for one sample.The following data was provided (reference range: >/= 50 au/ml is positive): first sample: (b)(6) initial result = 76.1 au/ml (cord blood serum) (b)(6) initial result = 42 au/ml (cord blood heparin) no impact to patient management was r6)eported.

• 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
• 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: 12664215
• MDR Text Key: 277366961
• Report Number: 3008344661-2021-00187
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: VM
• 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: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2021
• Device Catalogue Number: 06S61-22
• Device Lot Number: 30307FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2021
• 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, AI02005; ALNTY I PROCESSING MODU, 03R65-01, AI02005; ALNTY I PROCESSING MODU, 03R65-01, AI02005