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 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

Ortho performed batch review, complaint review by lot, donor history, and donor complaint review.Retain testing unable to be performed since event was reported on 12jan2018 and vs075 expired on 02jan2018.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 single patient failed to react with homozygous m antigen cell#1 from 0.8% selectogen lot# vs075 when tested on mts anti-igg gel cards on (b)(6) 2018.Customer retested single patient in question (different sample) on (b)(6) 2018 with a different lot of 0.8% selectogen and patient in question reacted 2+ against cell#1 with same lot of mts anti-igg gel cards customer reports qc not affected using ortho confidence kit and ab plasma as neg control.Customer reports no harm came to patient due to this event occurring.Problem description: issue started on: (b)(6) 2018.Frequency: 1x.Microtubes/wells or cell (donor #) affected: cell#1 from lot#vs075 methodology used: manual, incubation time (for manual test only):manual, pattern observed: neg.Reaction grade obtained: neg, customer was expecting: pos.Test repeated: yes, result obtained by repeating:pos 2+, method used to repeat: manual gel.Customer reports storing and testing mts gel card and reagents according to ifu.Customer reports patient in question was not transfused at her institute.Patient in question did not have past antibody history and previous antibody screen history is neg.Customer sent sample to reference lab were they have identified patient to have anti-m, customer reports reference lab tested patient in question in tube methodology detail any maintenance failure or maintenance inadequately performed that would be relevant for the issue : up to date.Tsc asked customer to retest patient in question with old (expired lot of cells for troubleshoooting reasons and customer reports 2+ grade against cell#1).Tsc discussed with customer cell suspension and manual technique when mixing that may be too weak and not enough antigen sites available when initial sample tested in manual gel.Tsc asked customer if patient transfused at other hospital, customer does not know.Customer content with documentation of event and no longer using product in question due to product expired.

• 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: matthew p wictome ; 1001 route 202; raritan, NJ 08869 ; 9082188223
• MDR Report Key: 7242368
• MDR Text Key: 99790049
• Report Number: 2250051-2018-00011
• 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: 02/05/2018

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: 01/02/2018
• Device Catalogue Number: 6902315
• Device Lot Number: VS075
• Other Device ID Number: 10758750007653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2018
• Initial Date FDA Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2017
• 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