MAUDE Adverse Event Report: ORTHO CLINICAL DIAGNOSTICS REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL A

Catalog Number 6902315

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 11/22/2017

Event Type  malfunction  

Manufacturer Narrative

Ortho performed retain testing, batch review, complaint review by lot, donor history, and donor complaint review.Based upon the results of this investigation, the reported customer issue was unable to be confirmed.All results were satisfactory.Sample was not returned to ortho for further investigation.(b)(4).

Event Description

Customer contacted tsc to report an issue where cell#2 of 0.8% selectogen vs072 presumably failed to detect an anti-big e antibody.Customer is from a small regional reference lab and her client's patient had a history of having an anti-big e.The testing was performed on (b)(6) 2017 and there is no sample left for additional testing.This lab does not have commercially prepared anti-big e to antigen type the cell in question.Qc passed on the day of use with ortho confidence kit and anti-igg gel card.The customer was not aware before testing that the patient had history of an anti-big e and has no additional information on the method that was used to initially detect the antibody since it was not done at her reference lab.The false negative result did not lead to any harm of the patient.Her client rejected the result since it did not match the patient's history.Issue started on: (b)(6) 2017.Methodology used: gel by manual method.Incubation time (for manual test only): 15 min.Test repeated: no.Patient/sample data: edta.Patient pregnant: unknown.List of medications: unknown.Transfusion history: unknown.Cards /cassettes/ storage condition temperature: as per ifu visual appearance before use: acceptable as she recalls reagent red blood cell storage and handling: as per ifu stored underneath direct light source: no protocol details (for customer working in manual methods): pipette used: mts compatible equipment.Customer did not have the ifu for the product.It was emailed and tsc reviewed the following limitation with the customer "for antibody detection and identification, different serological methods are optimal for different antibodies.No single antibody screening or identification method optimally detects all antibodies.In some low ionic strength test systems, certain anti-e and anti-k antibodies have been reported to be nonreactive.".

• Brand Name: REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL A
• Type of Device: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): ORTHO CLINICAL DIAGNOSTICS; 1001 route 202; raritan NJ 08869
• 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: 7178358
• MDR Text Key: 97859785
• Report Number: 2250051-2018-00007
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/10/2018

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 Expiration Date: 12/19/2017
• Device Catalogue Number: 6902315
• Device Lot Number: VS072
• Other Device ID Number: 10758750004041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2017
• Initial Date FDA Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2017
• 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