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 04/18/2018

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

Customer contacted tsc to report single patient failed to react with cell#3 and cell#6 of (b)(4)% resolve panel a lot# vra299 and customer could not identify anti-e from panel.Tsc requested but customer did not provide lot# of mts igg gel cards.Customer initially tested antibody screen on patient sample on provue analyzer with (b)(4)% surgiscreen cell#2 reacted 2+.Customer reports qc on 0.8% resolve panel a in question passed when tested with anti-c.Issue started on: (b)(6) 2018.Frequency: 1x.Microtubes/wells or cell (donor #) affected:cell#3 and #6.Methodology used: manual gel.Incubation time (for manual test only):15 min.Reaction grade obtained: neg.Customer was expecting: pos.Test repeated: no.Customer reports storing and testing mts gel cards and reagents according to ifu.Customer tested patient with (b)(4)% resolve panel c.Customer reports untreated panel c vial# 3 reacted with 3+ pos reaction, all other cells in untreated panel negative.Customer reports (b)(4)% resolve panel c treated , cell#3 and cell#6 both reacted with 3+ pos reaction.Customer reports if (b)(4)% resolve panel c was not performed, anti -e that was identified could have been missed.Detail any maintenance failure or maintenance inadequately performed that would be relevant for the issue : up to date.Tsc asked customer if repeat testing done, customer reports no.Tsc asked customer to phenotype cell #3 and #6 from (b)(4)% resolve panel a in question: customer refused.Customer demands replacement and is frustrated with product.Tsc discussed with customer if cells were properly mixed in (b)(4)% resolve panel a , customer reports yes.Tsc will replace one (b)(4)% resolve panel a from alternate lot #, customer agreed.

• 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: 7512043
• MDR Text Key: 108734069
• Report Number: 2250051-2018-00052
• Device Sequence Number: 1
• Product Code: KSZ
• Combination Product (y/n): N
• 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: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 05/08/2018
• Device Catalogue Number: 6902317
• Device Lot Number: VRA299
• Other Device ID Number: 10758750007677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2018
• 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