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

Catalog Number 719610

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Device (2588)

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

Event Date 09/02/2018

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

Report 1 of 2 (patient sample from (b)(6) 2018).Account reports one patient with anti- big c that failed to react with selectogen lot s061 when converted to 0.8% in manual gel.Patient tested on (b)(6) 2018.Patient originally presented on (b)(6) 2018 and tested with different 0.8% selectogen lot and anti-igg card.The 0.8% resolve panel a clearly identified anti-big c (all reactions 1+).Auto control negative.Dat negative in tube from both (b)(6) and (b)(6).Patient re-presented on (b)(6) 2018.Now she was tested with selectogen lot s061 converted to 0.8% in gel with the same lot of cards.Screen was negative.Account repeated testing using both samples ((b)(6) 2018 sample and (b)(6) 2018 sample) with lot s061 converted to 0.8% and both were negative.Sample from (b)(6) 2018 also negative with s061.Female with autoimmune hemolytic anemia.(b)(6).No harm came to patient.Only big c negative units selected for transfusion.Issue started on: (b)(6) 2018.Reported 9-7-18.Methodology used: manual gel.Incubation time (for manual test only): 15 minutes.Reaction grade obtained: negative with lot s061 converted to 0.8%.Customer was expecting: 1+.Test repeated: yes.Result obtained by repeating: same results.Method used to repeat: manual gel.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.Ortho care had account repeat testing with new, different of screening cells they just received, and now positive 1+ reactions were seen which corresponds with anti-big c.They used both samples from (b)(6) and (b)(6).They then repeated testing again with s061 converted to 0.8% and received negative results again.Ortho care confirmed that customer made the correct dilution with their 3% cells and diluent 2.

• 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: 7892972
• MDR Text Key: 120839590
• Report Number: 2250051-2018-00083
• 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
• Type of Report: Initial
• Report Date: 09/19/2018

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: Other
• Device Expiration Date: 09/11/2018
• Device Catalogue Number: 719610
• Device Lot Number: S061
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2018
• 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