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 01/06/2018

Event Type  malfunction  

Manufacturer Narrative

Ortho performed retain testing, batch review, complaint review by lot, donor history, and donor complaint review.Although the reported customer issue was unable to be confirmed, as a precaution the donor was permanently deferred.Based upon the results of this investigation.No harm came to any patients.Sample was not returned to ortho for further investigation.(b)(4).

Event Description

Report 2 of 4 (patient 1 manual gel).Account with two patients with anti-jka that failed to react with panel cell #7 from 0.8% resolve panel a lot vra292.Dates of testing: (b)(6) 2018.Account performed testing both on the vision and manual gel with mts anti-igg cards with the same negative results.Newer tech performed testing on one the patients and ruled out anti-jka based on the fact that cell was homozygous.Tech could not identify antibody.Dayshift was able to identify anti-jka based on testing from 0.8% resolve panel b lot vrb290.All jka positive cells reacted with this panel.As stated above, testing for vra292 was repeated in manual gel (15 minute incubation) and no reactivity with panel cell #7 noted again.Account feels like panel cell is not homozygous jka and possibly not jka positive at all.No harm came to either patient.Only jka negative cells selected for transfusion.Both patient's anti-jka were showing dosage.2+ reactivity with the homozygous cells.1+ to negative reactivity with the heterozygous cells.Account does perform their own jka antigen typings in tube.Account uses ortho bioclone.Account converted cell #7 to 3% and perform jka typing in tube.Result was negative macroscopically but positive microscopically.Qc on anti-jka bioclone was acceptable.Positive control selected was a heterozygous cell and it was 2+ macroscopically.Issue started on: (b)(6) 2018.Reported 1-22-18.Frequency: two patients.Microtubes/wells or cell (donor #) affected: cell #7 - vra292.Methodology used: vision and manual gel.Incubation time (for manual test only): 15 minutes.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 again.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.

• 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: 7248718
• MDR Text Key: 99931353
• Report Number: 2250051-2018-00019
• 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: 02/07/2018

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: 01/30/2018
• Device Catalogue Number: 6902317
• Device Lot Number: VRA292
• Other Device ID Number: 10758750007677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2017
• 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