MAUDE Adverse Event Report: ORTHO CLINICAL DIAGNOSTICS ORTHO REAGENT RED BLOOD CELLS 0.8% SELECTOGEN

Catalog Number 6902315

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 03/10/2017

Event Type  malfunction  

Manufacturer Narrative

Ortho performed retain testing, batch review, complaint review by lot, donor history, and donor complaint review.All results were satisfactory.Sample was not returned to ortho for further investigation.(b)(4).

Event Description

Event 1 of 2.Customer reporting isolated problem related to one sample.According to customer, sample with previous history of anti-kell is failing to react during antibody screen on provue analyzer.Approximately a week ago, sample was tested and antibody screen was reported as weak positive by provue with kell positive cells.Patient in question was transfused with packed cells during the past week.Amount of packed cells and date transfused not provided.Customer was not able to tell if patient received any plasma products, but did state patient was on iv fluids.New sample was tested on 3/14 on provue and now the antibody screen was negative.Testing performed using same lot of mts igg gel cards and vs004.Daily qc testing was acceptable.Issue started on: 3-14-17.Frequency: isolated to this one patient.Before calling, the customer reviewed the antibody screen results on the provue for sample in questions and reactions were negative.Ortho care reviewed with customer, the possibility that titer of the antibody is diluted further with fluid and recommend customer repeated antibody screen using manual gel method.Customer agreed to repeat antibody screen.Ortho care followed up with customer and was told upon repeat testing of sample using manual gel method, the antibody screen was also negative.Customer agreed that issue is related to sample possibly due to dilution of titer of antibody.Testing for manual gel method was performed using the same lot # of gel cards and screening cells.

• Brand Name: ORTHO REAGENT RED BLOOD CELLS 0.8% SELECTOGEN
• 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: marta carnielli ; 1001 route 202; raritan, NJ 08869 ; 9082188223
• MDR Report Key: 6456390
• MDR Text Key: 72113359
• Report Number: 2250051-2017-00025
• 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: 04/03/2017

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 Expiration Date: 03/28/2017
• Device Catalogue Number: 6902315
• Device Lot Number: VS004
• Other Device ID Number: 10758750007653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2017
• Initial Date FDA Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2017
• 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