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

Catalog Number 6902319

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

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

Event Date 08/03/2017

Event Type  malfunction  

Manufacturer Narrative

Ortho performed retain testing, batch review, complaint review by lot, donor history, and donor complaint review.All results were satisfactory.Sample was not returned to ortho for further investigation.(b)(4).

Event Description

Event 1 of 2: customer contacted tsc to report cell# 3 (b)(6) and cell# 6 (b)(6) failed to react with 2 patients when testing in manual gel method opened untreated 0.8%; resolve panel c; lot# vrc234; exp 08/15/17; tested on mts igg gel cards.Issue started on:(b)(6) 2017.Frequency: 2x.Incubation time (for manual test only): 15 min.Pattern observed: false neg.Reaction grade obtained: neg.Customer was expecting: pos.Test repeated: yes with treated ficin cells.Result obtained by repeating: 3+ pos in cells #3 and #6.Method used to repeat: manual gel.Customer reports no haze or hemolysis noted in red cell reagents in mts gel cards.Customer reports patient last transfused on (b)(6) 2017.Customer reports patient initially tested against 0.8% selectogen with a positive result.Customer reports qc against 0.8% resolve panel c not affected.Customer reports opened treated 0.8%; resolve panel c; lot# vrc234; exp: 08/15/17; cell # 3 and # 6 identified anti-e, tested on mts buffered gel cards.Tsc recommended customer to antigen type cells/donor #3 and #6 for anti-e in question, customer agreed and reports 3+ reaction for e antigen in question.Tsc discussed with customer event could possibly be isolated to patient samples.Tsc emailed customer ifu of 0.8% resolve panel c ifu and referred to interpretation: reactions obtained with 0.8% resolve panel c ficin treated are likely to be different than the reactivity obtained with the untreated panel as reactivity with certain antibodies will be enhanced while others are diminished or eliminated.Interpretation must be made considering the various effects of enzymes in antigen/antibody reaction.The following specificities are examples of antibodies whose reactivity may be enhanced when testing is performed with ficin-treated red cells: anti-d, -c, -e, -c, -e, -f, -jka, -jkb, -leb, -p1, -i, -ih, -vel, -pp1pk and -p.-tsc also referred customer to limitation section in ifu:12.For antibody detection and identification, different serological methods are optimal for different antibodies.No single antibody screening or identification method optimally detects all antibodies.In some low ionic strength test systems, certain anti-e and anti-k antibodies have been reported to be nonreactive.

• Brand Name: REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL C
• 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: 6797251
• MDR Text Key: 84948683
• Report Number: 2250051-2017-00064
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 08/15/2017

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: 08/15/2017
• Device Catalogue Number: 6902319
• Device Lot Number: VRC234
• Other Device ID Number: 10758750007691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2017
• Initial Date FDA Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2017
• 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