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 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

Ortho field engineer went on site for service.No repairs needed.Qc was run and verified by customer.Instrument is operating as expected.(b)(4).

Event Description

On (b)(6) 2018, a negative dat result on a cord blood tested on provue (s/n (b)(4)) was reported to a clinician.Because the newborn showed signs of jaundice, the physician requested that the dat be repeated.The sample was then retested on a different provue and in manual gel.Weak-1+ reactivity was noted.Due to the discrepant results obtained, the customer reviewed the results of 239 cord blood samples in which the baby was either group a or group b and the mother was group o.Samples had originally been tested on one of four provue instruments during the time period (b)(6) 2018 to (b)(6) 2018.Twenty one samples that had initially been reported as negative were repeated in manual gel.Five samples, originally reported as negative were now weak - 1+ in manual gel testing.Two of the five samples now testing as w-1+ in manual gel were initially tested on this same provue instrument (s/n (b)(4)).Sample (b)(6) was originally tested on (b)(6) 2018 and sample (b)(6) originally was tested on (b)(6) 2018.Report 1 of 3.

• 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: 7650391
• MDR Text Key: 113246741
• Report Number: 1056600-2018-00079
• Device Sequence Number: 1
• Product Code: KSZ
• Combination Product (y/n): N
• 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: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• 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: 3.1.1
• Other Device ID Number: 10758750006014
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2010
• 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