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

Catalog Number MTS213784

Device Problems False Negative Result (1225); Incorrect Or Inadequate Test Results (2456)

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

Event Date 05/31/2017

Event Type  malfunction  

Manufacturer Narrative

All three instruments have been investigated.On 6-2-2017 an ortho field engineer (fe) arrived at the customer site and performed the following: fe verified the camera settings was in the range of 101 to 128 and current setting was at 116 for two of the three provues and 117 on the third provue.Verified the spinners operation to make sure red cells are being suspended.Fe also verified the expected volumes and all were in range checked connections on dilator and all were tight, reviewed tiff pictures and images were clean, sharp and straight.Customer ran controls and all controls passed as expected.

Event Description

Two (2) out of 3.Customer reporting an incident of false negative result for antibody screen tested on provue 057-000-4311.Testing was repeated using manual gel method and results were positive(1+) with both screening cells.Additional testing using ficin treated cells, anti-d identified (2+).Customer then tested sample in question on provue serial # 057-000-4305 and 057-000-4307 and still reporting negative result for abs screen.All testing were performed with the same lot # of screening cells and gel cards.According to customer, on (b)(6) 2017, sample from pregnant female was tested on provue serial # (b)(4).(site had no prior history for patient in question).Antibody screen test was reported as negative.Mom gave birth and baby's blood type was group a with positive dat.To rule out abd incompatibility, elution was performed and anti-d was eluted from cord sample) (3+ positive).During investigation, customer then decided to repeat antibody screen on mom's sample.With manual gel testing of sample, abs was positive (1+).Customer then performed antibody id using panel c ( both treated and untreated cells ) and anti-d was identified.Customer then decided to repeat the antibody screen test on the other two provue and again saw negative result.

• 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: 6649675
• MDR Text Key: 78036211
• Report Number: 1056600-2017-00056
• 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: 06/19/2017

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2017
• Initial Date FDA Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2013
• 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