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

Catalog Number MTS213784

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 02/02/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that the most likely root cause of this event was sample related due to the patient receiving rh negative blood.Cl2015-187 explains the methodology of which the provue samples from the bottom of the tube.Since transfused cells have a higher hemoglobin they are heavier and are at the bottom of the tube explaining the negative rh typing on the provue.No reports of any incorrect or erroneous results reported as a result of this reported concern.

Event Description

Account reports discrepant results on a d typing on one patient.Sample initially tested on the provue.Sample tested as rh negative.Account then tested the same sample in tube- immucor reagent - sample tested as rh positive (4+).Sample repeated on the provue.Still rh negative.Transfusion history - patient had received one unit of rh negative blood.Ortho care had account repeat testing on the same sample in manual gel using the same lots of reagents.Sample now tested rh positive (sample tube was mixed prior to testing).Informed account that provue samples from the bottom of the tube.Since transfused cells have a higher hemoglobin they are heavier and are at the bottom of the tube explaining the negative rh typing on the provue.Manual gel testing was used with mixed cells yielding a rh positive testing.Account satisfied with explanation.Call originally logged against the cards at the time of receipt.See (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: 7293030
• MDR Text Key: 101147699
• Report Number: 1056600-2018-00005
• 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: 02/23/2018

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: 02/02/2018
• Initial Date FDA Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1