MAUDE Adverse Event Report: MICROTYPING SYSTEMS ORTHO PROVUE; AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM

Catalog Number MTS213784

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Information (3190)

Event Date 03/27/2019

Event Type  malfunction  

Manufacturer Narrative

This instrument was investigated.On 03/30/2019 an ortho fe arrived on site and inspected images and noticed there was debris on top of the visor which at times would be around the well areas.Fe also inspected the error log and did find that volume error posted.Fe replaced cavro and syringe.Successfully ran wad diagnostics.Customer ran, verified and accepted qc.No erroneous results were reported due to this issue.

Event Description

Customer reports the provue gave false negative crossmatch results.Manual gel testing was done using the same samples and the customer observed a 1+ reaction.No erroneous results were reported due to this issue.Initial crossmatch testing with patient sample (b)(6): unit id# (b)(6) 1+; unit id# (b)(6) flagged with a; unit id# (b)(6) result was negative/small cell button.Manual gel repeat testing of the same revealed all reactions were 1+.Prior to this issue, the provue had service order created due to probe dispense (b)(4) and gelcam unexpected volume, (b)(4).

• Brand Name: ORTHO PROVUE
• Type of Device: AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM
• Manufacturer (Section D): MICROTYPING SYSTEMS; 1295 southwest 29th avenue; pompano beach FL 33069
• Manufacturer Contact: matthew p wictome ; 1001 route 202; raritan, NJ 08869 ; 9082188223
• MDR Report Key: 8503940
• MDR Text Key: 152807316
• Report Number: 1056600-2019-00011
• Device Sequence Number: 1
• Product Code: KSZ
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: MTS213784
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1