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

Catalog Number 6902317

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 03/02/2018

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

Account reports one patient with no previous history with anti-big e.Patient was positive (1+) with the big e positive cell on 0.8% selectogen, but failed to react with any big e positive cells on 0.8% resolve panel a lot vra296.Account then performed 0.8% resolve panel b and all big e positive cells reacted 1+.Anti-igg card was used.No erroneous results released.Only big e negative blood was selected for transfusion.No harm came to patient.Issue started on: (b)(6) 2018.Frequency: one patient.Methodology used: manual gel.Incubation time (for manual test only): 15 minutes.Reaction grade obtained: 1+ for the big e positive cells on 0.8% selectogen and 0.8% resolve panel b, no reactivity with big e positive cells on vra296.Customer was expecting: all big e positive cells to be positive.Test repeated: yes.Account did repeat the big e positive cells on 0.8% resolve panel a - they did not extend the incubation time.Result obtained by repeating: they were still negative.Method used to repeat: manual gel.Daily qc performed and found to be acceptable.Sample type: edta plasam.Cards /cassettes/rbc storage condition temperature: per ifu.Visual appearance before use: all reagents have a normal appearance prior to use.

• 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: 7369118
• MDR Text Key: 103923179
• Report Number: 2250051-2018-00030
• 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: 03/25/2018

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: 03/27/2018
• Device Catalogue Number: 6902317
• Device Lot Number: VRA296
• Other Device ID Number: 10758750007677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2018
• Initial Date FDA Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2018
• 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