MAUDE Adverse Event Report: DIASORIN MOLECULAR LLC SIMPLEXA DIRECT AMPLIFICATION DISC; REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM

Model Number	MOL1455
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer complaint complaint wo# (b)(4) was received on 5/9/2023 alleging a leakage on the direct amplification disc mol1455 lot p17731n while running the simplexa congenital cmv direct kit mol2255.After the 1st run of a full 8-well disc, fluid was observed on the outside of wedge 4.On the next run of another full 8-well disc, fluid was observed outside of wedges 4 and 8.Each sample that leaked was invalidated due to the internal control not being detected.No patient testing was performed as the leak occurred during customer training using known postive samples, known negative samples, and control samples (nc, pc).No patient harm occurred.
Additional Manufacturer Narrative
A customer complaint was received on 5/9/2023 alleging two events of leakage observed on two (2) direct amplification discs (reference number: mol1455, lot number: p17731n) while running the simplexa¿ congenital cmv direct kit (ref no.: mol2255, lot: 17780n) in two independent runs.The two corresponding run files were provided on 5/9/23 to dsm technical services for analysis and they showed results invalid for 3 wedges out of 16 (1 invalid out of 8 wedges on the first run, 2 invalids out of 8 wedges on second run).Of the three (3) wedges that were invalid, the internal control and/or positive control signals did not amplify during the run, indicating the leakage likely occurred prior to run completion.Pictures, provided by the customer, showed fluid on the outside of wedge 4 on each disc of each run, visibly reduced fluid volume in the reaction chambers of all three (3) wedges, as well as traces of fluid on the instrument's barcode reading window.Review of the production batch record for ref no.Mol1455, lot: p17731n and the individual disc ref no.Mol1452, lot: p17046n, showed no abnormalities during production.The lot met all qc specifications and there were no nonconformances associated with the lot prior to release on 2/2/2023.Five (5) retain discs from the direct amplification disc kit ref no.Mol1455, lot: p17731n were previously tested in early may 2023, for a previous unrelated complaint.No leaks were observed in 4 out of 5 discs, while one (1) event of leak occurred on one (1) disc at the fourth time re-use, in 3 wedges.With the aim to further investigate this particular dad lot and if the issue was assay specific, additional testing has been conducted on 6/6/2023, when five (5) discs were tested for multiple reuse with simplexa¿ congenital cmv direct kit (ref no.: mol2255, lot: 17780n).All five (5) discs leaked between the third and fifth reuse.This is the second complaint for disc leaks on mol1455, lot: p17731n.The initial investigation has resulted in the potential cause being due to a supplier raw material lot with lower adhesive adhesion value.This weakness, when combined with specific assay mixing steps at high temperature and spin, could result in compromised discs.Capa-00366 has been opened to identify all root causes and contributing factors which could result in compromised discs.Additionally, a recall investigation has been initiated to determine if a recall is required, the potential scope of the recall and customers impacted.The recall investigation is expected to be completed on 6/14/2023.Although no death or serious injury has occurred in this complaint, the confirmed malfunction with ref.No.Mol1455, lot: p17731n has the potential for false positive congenital cmv results (due to contamination).False positive ccmv results carry a high risk to patient per diasorin document; (b)(4) (severity = 4/disastrous).This mdr is being filed ahead of the capa investigation conclusion to capture the potential for a high risk event should the malfunction recur.

• Brand Name: SIMPLEXA DIRECT AMPLIFICATION DISC
• Common Device Name: REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM
• Manufacturer (Section D): DIASORIN MOLECULAR LLC; 11331 valley view street; cypress CA 90630
• Manufacturer (Section G): DIASORIN MOLECULAR LLC; 11331 valley view street; cypress CA 90630
• Manufacturer Contact: kwang kim ; 11331 valley view street; cypress, CA 90630 ; 5622406323
• MDR Report Key: 17101714
• Report Number: 2023365-2023-00011
• Device Sequence Number: 7388117
• Product Code: OOI
• UDI-Device Identifier: 30816101025092
• UDI-Public: (01)30816101025092(10)P17731N(11)2023-01-27
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: MOL1455
• Device Catalogue Number: MOL1455
• Device Lot Number: P17731N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown