MAUDE Adverse Event Report: MICROTYPING SYSTEMS ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS¿ ANTI-IGG CARD; MTS GEL CARDS - FOR DIRECT AND INDIRECT ANTIGLOBULIN TEST

Catalog Number MTS084024

Device Problems Incorrect Or Inadequate Test Results (2456); Missing Test Results (3267)

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

Event Date 10/07/2017

Event Type  malfunction  

Manufacturer Narrative

Lot numbers of gel cards or reagent red cells were not provided therefore, retain testing, batch review, and complaint reviews were unable to be performed.The reported information in the abstract was unable to be confirmed.Samples were not provided to ortho for further investigation.(b)(4).

Event Description

Report 2 of 5.Ortho representative nick gould performed a literature review and requested that this abstract be documented."1.Title: evaluation of the ih-1000? immunohematology gel system for use in a hospital transfusion service.Author/inventor: laufer, melissa j.A.(correspondence); zollman, marianne m.; brown, deanna; madole, mandy; jack, elizabeth; williams, candace corresponding author facility: biorad laboratories inc., carson tahoe regional medical centre, carson city, nv.Source transfusion, (september 2017) vol.57, supp.Supplement 3, pp.141a-142a.Abstract number: cp199.Meeting info: aabb annual meeting 2017.San diego, ca, united states.07 oct 2017-10 oct 2017 issn: 0041-1132.Abstract.Background/case studies: the purpose of this study was to evaluate the performance of the ih-1000? automated blood group analyzer (bio-rad laboratories, inc.) in a transfusion service.The analyzer was compared to their existing platform; the provue? (ortho clinical diagnostics).The facility's objective was to continue utilizing gel technology with a different manufacturer for higher throughput and better efficiency.This hospital facility performs approximately 8k types and screens per year.Study design/methods: edta samples were tested on the ih-1000 with ih-system gel cards for abo/rh (forward and reverse); antibody screening (abs); abo/rh unit confirmation; crossmatch compatibility (igg); antibody identification (abid); and weak d.Anti-igg direct antiglobulin test (dat) was performed on both edta samples and edta cord blood samples.These tests were compared to the provue for concordance.Additional samples tested with anti-igg,-c3d were correlated against tube testing for the data and antigen typing for: c, c, e, e, and k.Results/findings: the ih-1000 had 100% concordance for all blood grouping assays.For ahg assays, the ih-1000 detected an (1) anti-jka+e, (2) anti- fya+warm antibody, (3) antibody to a high incidence antigen and (4) a warm antibody that were missed by the provue.The ih-1000 identified one additional (5) anti-e not identified on the provue.Discrepancies were also noted with the non-cord dat results.Five samples were positive on the ih-1000 with anti- igg,-c3d vs.Tube testing; reflecting the increased sensitivity of gel methodology over tube.Conclusion: this study demonstrated that the ih-1000 analyzer and associated ih-system? gel cards are equivalent to the ortho provue.With random access capability, minimal operator touchpoints, broad test menu and excellent assay performance, the ih-1000 is an ideal immunohematology system for the hospital transfusion service environment.(table presented)." other relevant details: tsc made multiple attempts to contact the customer via phone and email requesting details of the event but no response has been received to date.Contact dates: 4/30,5/1/2018, and 5/7/2018.Call will be reopened if/when customer calls back.

• Brand Name: ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS¿ ANTI-IGG CARD
• Type of Device: MTS GEL CARDS - FOR DIRECT AND INDIRECT ANTIGLOBULIN TEST
• Manufacturer (Section D): MICROTYPING SYSTEMS; 1295 southwest 29th avenue; pompano beach FL 33069
• Manufacturer (Section G): MICROTYPING SYSTEMS; 1295 southwest 29th avenue; pompano beach FL 33069
• Manufacturer Contact: matthew p wictome ; 1001 route 202; raritan, NJ 08869 ; 9082188223
• MDR Report Key: 7530081
• MDR Text Key: 109501713
• Report Number: 1056600-2018-00068
• 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
• Type of Report: Initial
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: MTS084024
• Device Lot Number: UNKOWN
• Other Device ID Number: 10758750005994
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2017
• 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