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

Catalog Number	09N78-095
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is in process.A follow-up report will be submitted when the investigation is complete.As the event occurred over multiple run dates, the following mdrs have been submitted with the following date of occurrences and reagent lot numbers: 3005248192-2023-00265 run date (b)(6) with reagent lot 394118, 3005248192-2023-00266 run date (b)(6) with reagent lot 394118, 3005248192-2023-00267 run date (b)(6) with reagent lot 394118, 3005248192-2023-00268 run date (b)(6) with reagent lot 394118, 3005248192-2023-00270 run date (b)(6) with reagent lot 394118.
Event or Problem Description
The customer identified falsely positive alinity m sars-cov-2 results for forty patients.The customer noted that as a routine matter, any result with a cycle number (cn) >35 is usually repeated.The customer provided results for 29 samples.The following sid(s) occurred on the date of event (b)(6).Run date (b)(6) 2023 sid (b)(6) initial result positive (cn 38.53), repeated on (b)(6)2023 under sid (b)(6) result negative (cn -1).Run date (b)(6)2023 sid (b)(6) initial result positive (cn 39.84), repeated on (b)(6)2023 under sid (b)(6) result negative (cn -1).Run date (b)(6) 2023 sid (b)(6) initial result positive (cn 40.18), repeated on (b)(6)2023 under sid (b)(6) result negative (cn -1).Run date (b)(6)2023 sid (b)(6) initial result positive (cn 38.08), repeated (b)(6)2023 with result positive (cn 39.66) and (b)(6)2023 under sid (b)(6) result negative (cn -1).Run date (b)(6)2023 sid (b)(6) initial result positive (cn 39.03), repeated on (b)(6)2023 under sid (b)(6) rpt result negative (cn -1).Run date (b)(6)2023 sid (b)(6) initial result positive (cn 38.65), repeated on (b)(6)2023 under sid (b)(6) rpt result negative (cn -1).Run date (b)(6) sid (b)(6) initial result positive (cn 39.05), repeated on (b)(6)2023 under sid (b)(6) rpt result negative (cn -1).Run date (b)(6)2023 sid (b)(6) initial result positive (cn 36.88), repeated on (b)(6)2023 under sid (b)(6) rpt result negative (cn -1).Run date (b)(6)2023 sid (b)(6) initial result positive (cn 39.43), repeated on (b)(6)2023 under sid (b)(6) rpt result negative (cn -1).Run date (b)(6)2023 sid (b)(6) initial result positive (cn 37.63), repeated on (b)(6)2023 under sid (b)(6) rpt result negative (cn -1).Run date (b)(6)2023 sid (b)(6) initial result positive (cn 38.05), repeated on (b)(6)2023 under sid (b)(6) rpt result negative (cn -1).Run date (b)(6)2023 sid (b)(6) initial result positive (cn 39.08), repeated on (b)(6)2023 under sid (b)(6) rpt result negative (cn -1).Run date (b)(6)2023 sid (b)(6) initial result positive (cn 38.17), repeated on (b)(6)2023 under sid (b)(6) rpt result negative (cn -1).Run date (b)(6)2023 sid (b)(6) initial result positive (cn 37.46), repeated on (b)(6)2023 under sid (b)(6) rpt result negative (cn -1).Run date (b)(6)2023 sid (b)(6) initial result positive (cn 39.42), repeated on (b)(6)2023 under sid (b)(6) rpt result negative (cn -1).Run date (b)(6)2023 sid (b)(6) initial result positive (cn 39.42), repeated on (b)(6)2023 under sid (b)(6) rpt result negative (cn -1).Run date (b)(6)2023 sid (b)(6) initial result positive (cn 37.69), repeated on (b)(6)2023 under sid (b)(6) rpt result negative (cn -1).Run date (b)(6)2023 sid (b)(6) initial result positive (cn 41.8), repeated on (b)(6)2023 under sid (b)(6) rpt result negative (cn -1).There was no report of impact to patient management.
Additional Manufacturer Narrative
Investigation into this complaint included a customer data review, a quality data review and a complaint history review.Investigation is summarized as follows: retain sample evaluation.The file sample testing did not identify a product deficiency for the alinity m sars-cov-2 amp kit (list 09n78-095) lot 394118.Customer data review: customer result log files were reviewed.The runs which involved the discrepant result were valid and met assay specification requirements.The validity of the run 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 394118 is performing outside of established design performance specifications based on the elements reviewed in this section.Quality data review: device history record / batch record review: the device history records (dhr) review for the alinity m sars-cov-2 amp kit (list 09n78-095) lot 394118.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 the alinity m sars-cov-2 amp kit (list 09n78-095) lot 394118 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 this lot number.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 while using the alinity m sars-cov-2 amp kit (list 09n78-095) lot 394118.A product deficiency was not identified by this evaluation.Based on the results of the investigation elements, a product deficiency the alinity m sars-cov-2 amp kit (list 09n78-095) lot 394118 was not identified.

• Brand Name: ALINITY M SARS-COV-2
• 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: 18016958
• Report Number: 3005248192-2023-00269
• Device Sequence Number: 15087837
• Product Code: QJR
• UDI-Device Identifier: 00884999049222
• UDI-Public: (01)00884999049222(10)394118(17)240810(240)09N78-095
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2023

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: 08/10/2024
• Device Catalogue Number: 09N78-095
• Device Lot Number: 394118
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2023
• 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