MAUDE Adverse Event Report: MOLECULAR DESIGNS/ASSURANCE SCIENTIFIC LABS/STREAMLINE SCIENTIFIC COVID-19 PANEL, LARGE TUBE; COVID-19 MULTI-ANALYTE ANTIGEN DEVICE

Catalog Number T-COV-001-A

Device Problems Product Quality Problem (1506); Incorrect, Inadequate or Imprecise Result or Readings (1535); Contamination of Device Ingredient or Reagent (2901)

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

Event Date 05/19/2023

Event Type  malfunction  

Event Description

We have concluded that laboratory service partners (lsp)'s covid-19 large tube (clt) kits from streamline scientific and molecular designs are contaminated and likely have been since november 2022 when we began offering this test.The lab has been releasing results all this time and this likely lead to some incorrect results being released.Since the first incident of mass contamination, the lab had adopted a policy of retesting any samples that resulted positive that amplified for n1 after 32 ct, to help prevent any false positives from being released.(the procedure provided to us from streamline stated any amplification of n1 before 40 ct was a true positive result).I have attached a run in which we tested 15 wells of water and reaction mix only to show the type of contamination we had been experiencing.Ideally, all these samples should be undetermined for n1 and rp resulting in an "invalid" result.Rp was detected in nearly every sample and n1 was detected in 3 samples (though n1 was detected above the cutoff in which we would retest the sample).Another lab has also confirmed the contamination by testing one of our reagent kits.We have halted this type of testing (clt) and have substituted a different method of pcr (pre-plated reagents) in the meantime.On this day, we tested 15 water samples in our 384-well quant and our 96-well quant.The water did not go through extraction so the most likely cause of this contamination would be from the reagents.These runs were sent to a reference lab along with an unopened testing kit.They confirmed the kit showed contamination.Reference reports: mw5118001, mw5118002.

• Brand Name: COVID-19 PANEL, LARGE TUBE
• Type of Device: COVID-19 MULTI-ANALYTE ANTIGEN DEVICE
• Manufacturer (Section D): MOLECULAR DESIGNS/ASSURANCE SCIENTIFIC LABS/STREAMLINE SCIENTIFIC; 2868 acton road; ste 206; birmingham AL 35243
• MDR Report Key: 17038641
• MDR Text Key: 316324848
• Report Number: MW5118000
• Device Sequence Number: 1
• Product Code: QMN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 05/26/2023

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 Operator: Lay User/Patient
• Device Catalogue Number: T-COV-001-A
• Device Lot Number: FG000951
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/31/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other