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

Catalog Number 06S60-22

Device Problem False Positive Result (1227)

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

Event Date 05/02/2021

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, list number 06s60-22 that has a similar product distributed in the us, list number 06s60-20.(b)(6).All the patient information was provided that was available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported false positive architect sars- cov-2 igg ii quant.Results for a patient that was admitted to the hospital with chronic kidney disease.The following data was provided (reference range: < 50.0 au/ml = negative, >/= 50.0 au/ml = positive): on (b)(6) 2021 at 12:40pm sid (b)(6) (first sample) = sars igg ii quant.Result = 5.9 au/ml (negative) / rt-pcr result = negative (tested 2 days prior) and covid igm (biomerieux) result = negative (tested same day) on (b)(6) 2021 at 1:27pm sid (b)(6) (second sample) = sars-cov-2 igg ii quant.Result = 106.1 au/ml (positive); the result was not released.Rt-pcr result = negative (tested on same day) the customer reran both samples after centrifugation and got values of 7.0 au/ml and 109.6 au/ml correlating with the original samples processed on (b)(6) 2021 and (b)(6) 2021.The customer stated both samples were icteric.The customer took the patient¿s heparin sample drawn on (b)(6) 2021 and tested it for sars-cov-2 igg ii quant and generated a result of 81.2 au/ml (positive).The customer then found the patient sample drawn for the blood bank that was used to process a crossmatch on (b)(6) 2021 in the morning for fresh frozen plasma (ffp) for the patient.The customer tested this sample for sars-cov-2 igg ii quant.And generated a result of 4.6 au/ml (negative).The customer checked the patient¿s history and found 2 units of ffp released for the patient on (b)(6) 2021 at 3pm and 6:30pm.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for false positive architect 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 possible as returns were not available.In-house testing for reagent lot 26269fn00 for both clinical specificity and sensitivity were completed using a retained sample of the complaint lot and indicates that the lot is performing acceptably.Device history record review on lot 26269fn00 did not identify any non-conformances, or deviations related to the customer¿s issue.Labeling was reviewed and found to adequately address the issue under review.The following patient data provided: on (b)(6) 2021, sid (b)(6) (first sample): sars igg ii quant.Result = (b)(6) / rt-pcr result = (b)(6) (tested 2 days prior) and covid igm (biomerieux) result = (b)(6) (tested same day) on (b)(6) 2021, sid (b)(6) (second sample): sars-cov-2 igg ii quant.Result = (b)(6); the result was not released.Rt-pcr result = (b)(6) (tested on same day).The customer reran both samples after centrifugation and got values of (b)(6) and (b)(6) correlating with the original samples processed on (b)(6) 2021.The customer stated both samples were icteric.The customer took the patient¿s (b)(6) sample drawn on (b)(6) 2021 and tested it for sars-cov-2 igg ii quant and generated a result of (b)(6).The customer then found the patient sample drawn for the blood bank that was used to process a crossmatch on (b)(6) 2021 in the morning for fresh frozen plasma (ffp) for the patient.The customer tested this sample for sars-cov-2 igg ii quant.And generated a result of (b)(6).In this case it is noted that the patient was admitted to the hospital with chronic kidney disease.Since the crossmatch sample also gave a negative result, it appears the issue is not with the sample.The positive result for cov-2 igg results appear after the fresh frozen plasma (ffp) transfusion.In this case, there could be possible transfer of antibodies from the transfused units of bloods, potentially leading to the positive results.Per the clinical performance section of the package insert, a study was performed to estimate the positive percent agreement (ppa) between the sars-cov-2 igg ii quant assay and the polymerase chain reaction (pcr) comparator.458 retrospective frozen serum and plasma specimens, collected at different times, were purchased from medical institutions, from a total of 142 subjects whose respiratory samples tested positive for sars-cov-2 by a pcr method and who also presented with covid-19 symptoms.The study data is presented both including and excluding immunocompromised specimens.The specimen cohort assessed in these studies consisted of nineteen (19) specimens from 7 immunocompromised patients.When the results from these specimens were excluded from the assessment, the ppa at = 15 days post-symptom onset is 99.37% (95 % ci 96.50, 99.97) and at = 15 days post-positive pcr is 98.81% (95% ci 93.56, 99.94).However, when the immunocompromised specimens were included in the assessment, the observed ppa at = 15 days post-symptom onset was 97.02% (95% ci: 93.22, 98.72) and = 15 days post-positive pcr result was 95.70% (95% ci: 89.46, 98.31).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.Per product labeling, heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.Patients routinely exposed to animals or to animal serum products can be prone to this interference, and anomalous values may be observed.Specimens from patients who have received preparations of mouse monoclonal antibodies for diagnosis or therapy may contain human anti-mouse antibodies (hama).Such specimens may show either falsely elevated or depressed values when tested with assay kits such as sars-cov-2 igg ii quant that employ mouse monoclonal antibodies.Based on the investigation architect sars-cov-2 igg ii quant.Reagent lot 26269fn00 is performing as intended, no systemic issue or deficiency of the architect sars-cov-2 igg ii quant.Reagent 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: 11863323
• MDR Text Key: 281333655
• Report Number: 3008344661-2021-00107
• 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: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• 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: 06S60-22
• Device Lot Number: 26269FN00
• Date Manufacturer Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I1000SR MOD, 01L86-01, (B)(6); ARC I1000SR MOD, 01L86-01, (B)(6)