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

Catalog Number 6902316

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

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

Event Date 03/30/2017

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 3.Customer contacted ortho care to report a false negative reaction with a patient with one homozygous cell for antigen e; cell #2 of the 0.8 surgiscreen lot# vss893.Customer tested with one opened set of 0.8% surgiscreen lot# vss893 exp 04.25.2017 when working with mts anti-igg gel cards and the antibody screen for this patient was negative.Patient received a transfusion of one rbc's unit in er.The patient was flown to university of utah.They ordered more units for transfusion and they repeated antibody screen.University (b)(6) called them back and reported they identified an anti-e antibody.Customer repeated antibody screen on the sample they had in storage with 0.8% surgiscreen lot# vss893 exp 04.25.2017 when working with mts anti-igg gel cards and again antibody screen still was negative.Customer ran e antigen typing on the segment from the unit that was transfused to the patient and the unit was antigen e negative.The patient was released from hospital in utah, and two days later was back to the (b)(6) er.A new specimen was drawn and they ran the antibody screen.This fresh sample was still negative.Patient returned to university (b)(6), and they repeated the antibody screen and reported anti-e again.Testing was performed in tube only with peg.Customer reported that sbb at (b)(6)recommended they should use both liss and peg antibody screen on every patient.Issue started on: (b)(6) 2017 reported 04.06.2017.(b)(6).Customer reports storing red cell reagents and mts gel cards according to ifu.Customer reports no signs of hemolysis or haze noted in red cell reagents.Card/cassette type: anti-igg gel card, started to be used: requested, not provided, rbc type:0.8% selectogen lot number: lot# vss893 exp 04.25.2017.Qc data: pass< last qc run: (b)(6) 2017, cards /cassettes/ storage condition temperature: according to ifu, visual appearance before use: acceptable, reagent red blood cell storage and handling: according to ifu.Other relevant details: patient with no previous history of antibodies.Customer ran resolve panel a and immucor panel for identification and to rule out.Anti-e was identified.Ortho care asked the customer to test with an alternate lot of anti-igg gel cards, but customer did not have an alternate lot.Ortho care asked customer if red cell reagents were allowed to come to room temperature, customer reports yes.Ortho care asked customer to test screening cell #2 with an anti-e antisera.Ortho care asked customer repeating the test extended the incubation time.Customer is going to check if more specimen is available to send returns to ocd for testing.All other patients and qc reacting as expected.Customer reported patient received transfusion of 2 units of rbc's on (b)(6) 2017 before being admitted at (b)(6).

• Brand Name: ORTHO REAGENT RED BLOOD CELLS 0.8% SURGISCREEN
• 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: marta carnielli ; 1001 route 202; raritan, NJ 08869 ; 9082188223
• MDR Report Key: 6498734
• MDR Text Key: 73255546
• Report Number: 2250051-2017-00032
• 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: 04/17/2017

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: 04/25/2017
• Device Catalogue Number: 6902316
• Device Lot Number: VSS893
• Other Device ID Number: 10758750007660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2017
• Initial Date FDA Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2017
• 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