MAUDE Adverse Event Report: CLARITY DIAGNOSTICS LLC CLARITY MONO TEST; MONO RAPID TEST

Catalog Number DTG-MONO

Device Problem Suction Failure (4039)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/07/2019

Event Type  malfunction  

Event Description

Nurse used pipettes in attempt to run monotest.Pipette would not pull blood in pipette from finger stick.Monotest cancelled.2 tests had same problem with drawing blood into pipette.Manufacturer response for mono rapid test, (brand not provided) (per site reporter).Clarity diagnostics customer service notified of equipment failure.Representative from clarity diagnostics arranged for 1 box of dtg-mono to be mailed by (b)(6) ground as replacement.

• Brand Name: CLARITY MONO TEST
• Type of Device: MONO RAPID TEST
• Manufacturer (Section D): CLARITY DIAGNOSTICS LLC; 1060 holland dr ste a; boca raton FL 33487
• MDR Report Key: 9347201
• MDR Text Key: 167156420
• Report Number: 9347201
• Device Sequence Number: 1
• Product Code: KTN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/07/2019,10/18/2019

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: Health Professional
• Device Catalogue Number: DTG-MONO
• Device Lot Number: 228F11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/07/2019
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/20/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 730 DA
• Patient Weight: 13