MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. ALINITY M SYSTEM; REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM

Model Number 08N53-002

Device Problems False Negative Result (1225); Unable to Obtain Readings (1516); Low Readings (2460)

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

Event Date 10/04/2022

Event Type  malfunction  

Event Description

Customer called and reported internal control (ic) failures on hiv-1 verification samples, therefore no actual patient samples were impacted.Elevated complaint investigation determined that the customer's observation was caused by the alinity m system (ln 08n53-02) having an incorrect instrument configuration due to the amplification detection unit (adu) missing plunger assemblies from the clamp bar.The plunger assemblies were missing from the clamp bar for all 12 wells on adu4 on the alinity m system.The system was out of configuration; therefore, the investigation was dispositioned as confirmed.

Manufacturer Narrative

Elevated complaint investigation confirmed the following specification not met: per alinity m instrument solidworks cad assembly, the clamp bar of the adu should contain 12 plunger assemblies (each consisting of a clamp piston, a washer, a wave spring, and a snap ring), on the alinity m system, ln 08n53-02.Impact on product functionality: the adu provides the functionality of thermal cycling and fluorescence signal detection and performs the real-time pcr for individual samples.Any time that the clamping force is compromised, for whatever reason, the potential exists for the thermal conductivity to also be compromised.Without proper thermal conductivity pcr can be inhibited, potentially resulting in delay of results or incorrect results.Conclusion: the potential hazard of delay in results was identified for the scenario where missing spring-loaded pistons may increase the rate of "invalid" test results due to internal control (ic) failures of the test sample.Based on review of this scenario, the potential hazard of delay of results associated with this issue is within the allowable time limit for alinity m assays.The potential hazard of incorrect results was identified for the scenario where the missing spring-loaded pistons could produce incorrect results, potentially producing false negative results or misquantitation low results due to ic read within control limits, while target is suppressed due to poor amplification.On (b)(6) 2023, a decision was made to issue a customer letter (urgent field notice / field corrective action) and a field action mandatory technical service bulletin to address the impacted instrument.Recommendation is that this action will be reported per 21 cfr 806.Associated severity is major.Field action fa-am-mar2022-288 was issued on (b)(6) 2023 as a urgent field notice / field correction action to notify the customer for alinity m system, serial number (b)(4) of the issue with their system and that an abbott representative will be in contact with them to replace the impacted amp detect unit.Field action was reported per 21 cfr806 to us fda via 3005248192-03/01/23-001c on (b)(6) 2023 and therefore is also reportable under 21cfr 803.Fda provided res (b)(4) for this action.

Manufacturer Narrative

Correction to field action number included within initial report.Report read field action "(b)(4)" and should have read "(b)(4)" was issued on (b)(6) 2023 as a urgent field notice / field correction action to notify the customer for alinity m system, serial number (b)(6) of the issue with their system and that an abbott representative will be in contact with them to replace the impacted amp detect unit.

• Brand Name: ALINITY M SYSTEM
• Type of Device: REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM
• 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: 16532668
• MDR Text Key: 311414907
• Report Number: 3005248192-2023-00137
• Device Sequence Number: 1
• Product Code: OOI
• UDI-Device Identifier: 00884999048034
• UDI-Public: 00884999048034
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 08N53-002
• Device Catalogue Number: 08N53-02
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 3005248192-03/01/23-001C
• Patient Sequence Number: 1