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

Catalog Number MTS213784

Device Problems Incorrect Or Inadequate Test Results (2456); Device Operates Differently Than Expected (2913)

Patient Problem Reaction (2414)

Event Date 01/31/2018

Event Type  malfunction  

Manufacturer Narrative

On 02/01/2018 an ortho field engineer (fe) arrived at the customer site to investigate potential card misreads.During image review, fe found post centrifuge images are not leveled.Fe attempted to correct issue but still could not get the image to be corrected.Fe ordered a gripper and a card holders to b installed the next day.On 02/02/2018, fe returned to install the parts following the service docs.He optimized all required adjustments, customer ran qc successful.Repairs have returned this instrument to expected operation.The investigation determined that the most likely root cause of this event was instrument related.No incorrect or erroneous results were reported as a result of this incident.There was no risk present at the time of the incident.There was no harm to any patient.

Event Description

The customer is contacting cts to report an event of provue camera misreading the antibody screen reactions.Customer repeated in manual gel, weak reactions are visually observed.Tsc had customer perform dat on the red cells and found they had a positive dat.Weak reactions are observable with naked eye, but provue is not flagging the cards.Tsc explained to the customer that the dat is not true aglutition.Customer wants service to check the provue.

• 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 (Section G): ORTHO CLINICAL DIAGNOSTICS; 1001 route 202; raritan NJ 08869
• Manufacturer Contact: matthew p wictome ; 1001 route 202; raritan, NJ 08869 ; 9082188223
• MDR Report Key: 7250807
• MDR Text Key: 99912752
• Report Number: 1056600-2018-00004
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 02/08/2018

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: Medical Technologist
• Device Catalogue Number: MTS213784
• Device Lot Number: 3.2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2006
• 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