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

Model Number QS-0025 OR QS-0500

Device Problem Biocompatibility (2886)

Patient Problems Local Reaction (2035); Swelling/ Edema (4577)

Event Date 03/08/2022

Event Type  Injury  

Manufacturer Narrative

The manufacturer (statsure diagnostic systems) was contacted regarding any changes in the material or manufacturing process.Statsure was able to confirm on (b)(6) 2022 that no changes have occurred.In 2021, sensitization 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.Review of the "overall biological safety assessment: quantisal family of oral fluid collection devices", which included the cytotoxicity and intracutaneous (intradermal) reactivity testing performed, found that the product met the requirements of iso 10993-1:2009 biological evaluation of medical devices part 1: evaluation and testing within a risk management process.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.Though no lot number was provided, a review of the customer's orders identified four quantisal lot numbers that were distributed to them (ek20266, ek20797, ek20838, or ek20648).A review of the batch records did not reveal any information relevant to this incident.Internal testing could not reproduce the customer complaint.The root cause of the adverse event remains unknown, though we suspect the reaction was due to the dental work.If the quantisal did cause the allergic reaction, the root cause cannot be conclusively determined as no sensitization reactions were observed in test animals.Immunalysis will continue to monitor and trend this issue.

Event Description

On (b)(6) 2022, it was reported that a patient developed a reaction following testing with a quantisal oral fluid collection device (no part description or lot number provided).It was reported that before the patient could get home, the inside of the mouth where the swab was held felt rough and irritated.By the next day, the patient's left cheek and jaw were swollen.The swelling had not receded after 8 days, so the patient went to urgent care and received a steroid shot.The patient was advised to head to the emergency room if the symptoms did not improve after 24 hours.Subsequent information revealed that the patient also received treatment from a dentist for teeth and gum conditions after the quantisal was used but before experiencing the cheek and jaw issues.It cannot be definitively determined whether the patient's symptoms were the result of the quantisal test or of the dental treatment.

• Brand Name: QUANTISAL
• Type of Device: ORAL FLUID COLLECTION DEVICE
• Manufacturer (Section D): STATSURE DIAGNOSTIC SYSTEMS; 1337 east 9th street; brooklyn NY 11230
• Manufacturer (Section G): STATSURE DIAGNOSTICS; 1337 e 9th street; brooklyn NY 11230
• Manufacturer Contact: mo bodner ; 1337 e 9th street; brooklyn, NY 11230 ; 9174174489
• MDR Report Key: 14098182
• MDR Text Key: 289175850
• Report Number: 3008264082-2022-00001
• Device Sequence Number: 1
• Product Code: PJD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: QS-0025 OR QS-0500
• Device Catalogue Number: QS-0025 OR QS-0500
• Device Lot Number: SEE NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other