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

Catalog Number MTS213784

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

Tsc discussed with customer different processes when comparing gel manual method to provue analyzer.Tsc also discussed with customer when loading 0.8% resolve panel a lot# vra296 onto provue that cell #3 may have possibly not been mixed properly limiting the e antigen sites to be exposed to anti-e in patient plasma sample.Tsc also discussed with customer titer of anti-e in patient plasma sample in question.Customer does not request service at this time as only one patient affected and does not request replacement product as qc not affected.The root-cause could not be confirmed although the most probable root cause is associated with an anti-e antibody being weak and/or at the detection limit of the technique and reagents used.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.A complaint review was performed dra# (b)(4).Only this event was reported for the provue in question.

Event Description

Customer contacted tsc to report upon performing antibody identification on a single patient sample with 0.8% resolve panel a lot# vra296, exp: 3.27.2018 tested on mts igg gel cards lot#081417001-03, exp: may 5 2018, failed to react with e homozygous donor (cell#3) from panel on provue analyzer.Customer tested 0.8% resolve panel a lot# vra296 in question with patient sample in manual gel method and patient got a 1+ pos reaction with donor/vial#3 (15 min incubation period).Customer reports no harm to patient due to this event and patient not transfused and this is new antibody identified.Customer initially tested patient in question with 0.8% selectogen lot# vs097, exp 3.27.2018 and patient reacted with cell#2, with a 2+ pos reaction on provue analyzer.

• Brand Name: ORTHO PROVUE
• Type of Device: AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM
• Manufacturer Contact: matthew p wictome ; 1001 route 202; raritan, NJ 08869 ; 9082188223
• MDR Report Key: 7436015
• MDR Text Key: 106712855
• Report Number: 1056600-2018-00057
• 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: 04/17/2018

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: Health Professional
• Device Catalogue Number: MTS213784
• Device Lot Number: 3.1.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2008
• 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