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

Catalog Number 6902316

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Date 02/19/2018

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

Report for manual gel.Account routinely performs parallel testing with a sister facility just to prove competency and reagent and equipment performance.Account was presented with a sample that contained anti-kell (1+) that failed to react on the provue and manual gel.Lot numbers in use: vss976.After initial testing on provue and manual gel account repeated it once again on provue - this time they got a question mark but manual review of the card was negative.No erroneous results released.Account testing sample as a competency sample and patient not transfused.Issue started on: (b)(6) 2018.Reported (b)(6) 2018.Methodology used: provue and manual gel.Incubation time (for manual test only): 15 minutes.Test repeated: yes - both manual gel ((b)(4)) and provue again.Result obtained by repeating: manual gel negative - provue - question mark but reaction looked negative upon manual review.Daily qc performed and found to be acceptable.Sample type: edta plasma.Cards /cassettes/rbc storage condition temperature: per ifu.Visual appearance before use: all reagents have a normal appearance prior to use.Customer called back and would like service on the provue to check it out.So opened.Service order (b)(4) completed: (b)(6) 2018 no onsite servicing required.Instrument operating as expected.

• Brand Name: ORTHO REAGENT RED BLOOD CELLS 0.8% SURGISCREEN
• 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: 7332816
• MDR Text Key: 102582984
• Report Number: 2250051-2018-00029
• 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: 03/12/2018

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: 03/13/2018
• Device Catalogue Number: 6902316
• Device Lot Number: VSS976
• Other Device ID Number: 10758750007660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2018
• 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