MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. ALINITY M RESP-4-PLEX AMP KIT; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Catalog Number	09N79-096
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported false positive results on the rsv target when running the alinity m resp-4-plex assay on their alinity m system.Questioned sids are listed below, which resulted as positive for the rsv target with high cycle numbers.Sid date tested rsv cn (cycle number) (b)(6), (b)(6), 2025 39.53 (b)(6), (b)(6), 2025 41.69 (b)(6), (b)(6), 2025 41.98 (b)(6), (b)(6), 2025 41.62 (b)(6), (b)(6), 2025 41.11 (b)(6), (b)(6), 2025 41.34 (b)(6), (b)(6), 2025 34.98 (b)(6), (b)(6), 2025 41.65 (b)(6), (b)(6), 2025 41.69 (b)(6), * (b)(6), 2025 41.14 (b)(6), (b)(6), 2025 41.27 *positive for covid tas reviewed the results, assay controls and internal control (ic) performance.All parameters were per assay specifications.The amplification curves are very late and low rising.Ic was amplified as expected.Samples with questionable results have been processed in separate sample racks from assay controls.Current troubleshooting includes review of assay processing unit (apu) involved, reaction vessel location, sample handling, and use of a fresh amplification reagent kit to exclude instrument contamination.Field service engineer (fse) visit was performed for instrument decontamination and environmental swabbing.Initial alinity results were released outside of the laboratory.Samples were retested on cephiad, which generated negative results.All results are reported through interface automatically and no questionable results have been discussed with providers.There was no report of impact to patient management.
Additional Manufacturer Narrative
An investigation is in process.A follow-up report will be submitted when the investigation is complete.Additional mdrs submitted for additional run dates: 3005248192-2025-00286 3005248192-2025-00287 3005248192-2025-00288 3005248192-2025-00289 3005248192-2025-00291 3005248192-2025-00292 3005248192-2025-00293 3005248192-2025-00294.
Additional Manufacturer Narrative
Investigation into this complaint included file sample testing, customer data review, quality data review and a complaint history review.The results of the investigation are summarized as follows: retain / file sample evaluation: the file sample evaluation for alinity m resp-4-plex amp kit (list 09n79-096) lot 414714 was performed.Testing for alinity m resp-4-plex amp kit list 09n79-096 lot 414714 met all validity criteria and acceptance criteria for all four analytes.Customer data review: results logs were available for six of the sample ids (sids) included in the original customer complaint.The assay met specification requirements as no error codes or flags were displayed for the quality control (qc) runs in the data attached to the ticket.The amplification curves appeared normal although delayed for the rsv analyte for five of the reported sids that were analyzed.The cycle threshold (ct) values (41.11, 41.65, 41.34, 41.69, and 41.27) are near the cycle threshold cutoff for the rsv analyte.This indicates the five samples were low positives.The ticket text states the samples were retested on another platform and received varying results.Sample id (sid): (b)(6) (replicate id: (b)(6)) exhibited normal, sigmoidal amplification consistent with positive results.Quality data review: device history record (dhr) review review of the manufacturing packet for alinity m resp-4-plex amp kit (list 09n79-096) lot 414714 did not identify any issues that could have led to the reported complaint.The quality control (qc) amp kit master lot testing for alinity m resp-4-plex amp kit (list 09n79-096) lot 414714 met all validity and acceptance criteria.No issues related to the reported complaint were reported during qc testing.Capa review: a lot specific capa search was performed to identify related existing internal quality records to the reported complaint during production or internal use.The capa review did not identify any existing internal records or nonconformances related to the reported complaint.Complaint history review: a lot specific complaint history review was performed to identify any similar complaints to the case being investigated, which reported discrepant false positive results for the rsv analyte while using alinity m resp-4-plex amp kit (list 09n79-096) lot number 414714.The complaint history review did not identify any additional complaints related to the reported issue for alinity m resp-4-plex amp kit (list 09n79-096) lot number 414714.Complaint trending was also reviewed.A trend violation was not identified as the upper control limit was not exceeded for product 9n79 (base list part number).No new adverse trend was identified.Based on the results of the investigation elements, a product deficiency for alinity m resp-4-plex amp kit (list 09n79-096) lot number 414714 was not identified.

• Brand Name: ALINITY M RESP-4-PLEX AMP 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 60018 3315
• Manufacturer Contact: albert chianello ; 1300 e. touhy ave.; des plaines 60018-3315 ; 2242064064
• MDR Report Key: 22822503
• Report Number: 3005248192-2025-00290
• Device Sequence Number: 8832250
• Product Code: QJR
• UDI-Device Identifier: 00884999049390
• UDI-Public: (01)00884999049390(10)414714(17)260408(240)09N79-096
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/08/2026
• Device Catalogue Number: 09N79-096
• Device Lot Number: 414714
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2025
• 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