MAUDE Adverse Event Report: VISBY MEDICAL, INC. VISBY MEDICAL COVID-19 POINT OF CARE TEST; VISBY MEDICAL COVID-19 TEST

Model Number PS-001260

Device Problem False Positive Result (1227)

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

Event Date 01/03/2022

Event Type  malfunction  

Manufacturer Narrative

The device with the reported false positive result was requested back for investigation; however, the customer discarded it.Since the device was not received, the allegation could not be confirmed.On page 12 of the instructions for use under limitations, it states the device cannot identify false positive results.There will be no corrective actions taken at this time as the complaint cannot be confirmed and root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Visby will continue to monitor for trends.Treatment/ therapy start and stop dates: start date: (b)(6) 2022.Stop date: (b)(6) 2022.

Event Description

The customer reported that in early (b)(6) 2022 a patient tested on a visby device and received a positive result then retested and received a negative result on another visby device.The customer stated the patient was between twenty to thirty years old.

• Brand Name: VISBY MEDICAL COVID-19 POINT OF CARE TEST
• Type of Device: VISBY MEDICAL COVID-19 TEST
• Manufacturer (Section D): VISBY MEDICAL, INC.; 3010 north first street; san jose CA 95134
• Manufacturer Contact: delia williams ; 3010 north first street; san jose, CA 95134 ; 6502577587
• MDR Report Key: 16455836
• MDR Text Key: 310434024
• Report Number: 3016608638-2023-00004
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2022
• Device Model Number: PS-001260
• Device Catalogue Number: PS-001260
• Device Lot Number: LN21110092
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2021
• 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
• Treatment: VISBY MEDICAL COVID-19 POWER ADAPTERPS-000288
• Patient Age: 21 YR