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

Catalog Number 6902315

Device Problems False Negative Result (1225); Incorrect Or Inadequate Test Results (2456)

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

Event Date 07/01/2017

Event Type  malfunction  

Manufacturer Narrative

Ortho performed batch review, complaint review by lot, donor history, and donor complaint review.Unable to perform retain testing since lot had expired prior to date of awareness.All results were satisfactory.Sample was not returned to ortho for further investigation.(b)(4).

Event Description

Manual gel testing (b)(4).Account performing validation on the vision.Account not live yet.Account selected a sample that was positive by competitor's technology with anti-jkb (3+ - 4+).Sample failed to react in gel lot vs034.Account tested sample both on the vision ((b)(4)) and manual gel (this event).No reactivity noted.Patient is a middle aged female.Account did not know her diagnosis.Sample was 1-2 days old.No erroneous results released.Sample tested only for vision validation.Reported 8-15-2017.Frequency: one patient only.Methodology used: vision and manual gel.Incubation time (for manual test only): 15 minutes.Account did not try extending the incubation time.Error code: no error codes received.Reaction grade obtained: negative.Customer was expecting: positive.Test repeated: yes by manual gel.Result obtained by repeating: negative.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.Tsc informed account that some antibodies respond better in different methodologies.Followed up with customer since lot expired 7-18-2017.Account states now that testing was performed some time ago.They are just now reporting for tracking purposes.Account could not provide exact date of testing.

• 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: 6845271
• MDR Text Key: 86843415
• Report Number: 2250051-2017-00070
• Device Sequence Number: 1
• Product Code: KSZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 09/06/2017

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: 07/18/2017
• Device Catalogue Number: 6902315
• Device Lot Number: VS034
• Other Device ID Number: 10758750007653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2017
• Initial Date FDA Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2017
• 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