MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. ALINITY M SARS-COV-2 AMPLIFICATION REAGENT KIT; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Catalog Number	09N78-095
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Elevated complaint investigation will be initiated.
Event or Problem Description
The customer reported 1 false negative (not detected) result on the alinity m sars-cov-2 assay.Sample id (sid) (b)(6).Was tested on (b)(6) 2023 on the alinity m sars-cov-2 assay and the result was "not detected." the customer reported that the patient was a staff member of the hospital who had tested positive with two at-home sars-cov-2 tests (quickvue at-home otc covid-19 test and quidel).The nurse managing the case also noted that the patient was symptomatic.The staff member (patient) had tested negative for sars-cov-2 on both the alinity m system as well as on the genexpert.The results were reported to the nurse monitoring the staff member and the nurse reported that the staff member was symptomatic and had tested positive on an at-home test.The technical application specialist (tas) downloaded the alinity m logs for the sample in question.The graphs for the sample appeared normal.The internal control for the sample was normal and no error codes were present for the sample.There was no report of impact to patient management.
Additional Manufacturer Narrative
Investigation into this complaint included a customer data review, retain / file sample evaluation, a quality data review, and a complaint history review.Investigation is summarized as follows: customer data review customer result log files were reviewed.The validity of the runs met assay specification requirements, and no error codes or flags were displayed for the run controls.There is no indication that the alinity m sars-cov-2 amp kit (list 09n78-095) lot 390319 is performing outside of established design performance specifications based on the elements reviewed in this section.Retain / file sample evaluation: alinity m sars-cov-2 amp kit (list 09n78-095) lot 390319 retain sample was tested by the complaint support team.Lot 382958 met all validity and acceptance criteria with no error codes.Quality data review: device history record / batch record review: the device history records (dhr) review for alinity m sars-cov-2 amp kit (list 09n78-095) lot 390319 (including the components) was performed.The manufacturing packets were reviewed to identify any issues related to the reported complaint during production of the lot components.No issues were identified.No issues were found during quality control (qc) testing.The products passed quality specifications at the time of release.Capa / non-conformance review: the capa review for alinity m sars-cov-2 amp kit (list 09n78-095) lot 390319 (including the components) was performed to identify any records that were potentially related to the reported complaint.The search did not identify any records related to the reported issue for these lot numbers.Complaint history review: a lot specific complaint history review was performed to identify any similar complaints to the ticket being investigated, which reported discrepant results (false negative) while using alinity m sars-cov-2 amp kit (list 09n78-095) lot 390319.A product deficiency was not identified by this evaluation.Based on the results of the investigation elements, a product deficiency for alinity m sars-cov-2 amp kit (list 09n78-095) lot 390319 was not identified.

• Brand Name: ALINITY M SARS-COV-2 AMPLIFICATION REAGENT KIT
• Common Device Name: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• Manufacturer (Section G): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• Manufacturer Contact: albert chianello ; 1300 e. touhy ave.; des plaines, IL 60018-3315 ; 2242064064
• MDR Report Key: 17684872
• Report Number: 3005248192-2023-00228
• Device Sequence Number: 20403612
• Product Code: QJR
• UDI-Device Identifier: 00884999049222
• UDI-Public: (01)00884999049222(10)390319(11)230424(17)231115(240)09N78-095
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/15/2023
• Device Catalogue Number: 09N78-095
• Device Lot Number: 390319
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown