MAUDE Adverse Event Report: STATSURE DIAGNOSTIC SYSTEMS QUANTISAL SALIVA COLLECTION DEVICES; ORAL FLUID COLLECTION DEVICE

Model Number	QS-0025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Itching Sensation (1943); Burning Sensation (2146); Sore Throat (2396); Confusion/ Disorientation (2553); Hyperresponsive to stimuli (4538); Swelling/ Edema (4577)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Despite multiple requests for the lot number, the customer was not responsive.Information on the customer's purchase history of past quantisal lot numbers was requested but not able to be obtained.As a result, a review of batch records cannot be performed.Similarly, an inquiry into the manufacturing records from the quantisal manufacturer (statsure diagnostic systems) cannot be executed without any device lot information.In 2020, cytotoxicity and intracutaneous (intradermal) reactivity testing for quantisal was performed.The test results showed that quantisal is safe when used according to the device's intended purpose and that the overall risk for biological safety is acceptable.The product met the requirements of iso 10993-1:2009.In 2021, maximization testing for four quantisal lots was performed.The study was performed according to iso 10993-10 guidelines.Both the stem & pad of the quantisal lots provided were extracted in saline and cottonseed oil.Thereafter, 34 guinea pigs were tested and exposed intra-dermally to the quantisal extracts.All animals were observed for adverse reactions.No sensitization reactions were observed in test animals.Attempts for additional information were made but the customer was not responsive.Based on the information that was made available, a root cause of the adverse event cannot be conclusively determined.Materials utilized for quantisal are generally recognized as safe.The swab that comes in contact with the patient is comprised of untreated cellulose and the stem is polypropylene.Immunalysis will continue to monitor and trend this issue.
Event or Problem Description
It was reported that a patient experienced a number of symptoms immediately following the collection of oral fluid with quantisal.Specifically, the patient reported experiencing burning under the tongue, a swelling of the tongue, burning and bloating in the stomach, burning and itchiness inside the ears, sensitivity to light and sound, listlessness, sore throat, acid coming up the throat, and slight disorientation.Through additional information, it was stated that the patient also described feeling a stinging sensation before placing the quantisal collection device under the tongue.Furthermore, it was also stated that the patient visited a medical professional five days after the oral fluid collection and appearance of symptoms.It is not yet known if the medical professional offered any treatment for the patient¿s reported symptoms.However, the medical professional did note that this patient should be excused from any future oral fluid testing.Additional information for this event was requested but has not yet been received.

• Brand Name: QUANTISAL SALIVA COLLECTION DEVICES
• Common Device Name: ORAL FLUID COLLECTION DEVICE
• Manufacturer (Section D): STATSURE DIAGNOSTIC SYSTEMS; 1337 east 9 street; brooklyn NY 11230
• Manufacturer (Section G): STATSURE DIAGNOSTIC SYSTEMS; 1337 east 9th street; brooklyn 11230
• Manufacturer Contact: mo bodner ; 1337 east 9 street; brooklyn, NY 11230 ; 9174174489
• MDR Report Key: 19602794
• Report Number: 3008264082-2024-00001
• Device Sequence Number: 7214485
• Product Code: PJD
• UDI-Device Identifier: 00840937105078
• UDI-Public: 00840937105078
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K942435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2024

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 Model Number: QS-0025
• Device Catalogue Number: QS-0025
• 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: 05/28/2024
• Initial Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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