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 MTS84024

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

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

Event Date 08/23/2017

Event Type  malfunction  

Manufacturer Narrative

Ortho performed batch review, complaint review by lot and master lot.All results were satisfactory.Retain testing unable to be performed since complaint was reported on (b)(6) 2017 and reagent red cell lot expired 18jul2017.Sample was not returned to ortho for further investigation.(b)(4).

Event Description

Customer contacted tsc to report that while performing comparison studies, a single sample with a (b)(6) antibody screen with anti-fya was crossmatched in mts igg gel card lot# 031417001-56.Exp: 12/30/2017 in manual gel method against a donor cell that was (b)(6) for fya antigen, and customer observed compatible results upon review but expecting incompatible results in manual gel method.Customer reports qc on mts igg gel cards passed.Issue started on: (b)(6) 2017.Frequency: 1 sample.Methodology used:manual gel method.Pattern observed: compatible.Reaction grade obtained: 0.Customer was expecting: incompatible.Test repeated: yes.Result obtained by repeating: compatible.Method used to repeat: manual gel method.Customer reports red cell reagents and mts gel cards stored according to ifu.Customer reports patient sample in question has not been transfused at customers facility and no harm to patient.Customer initially performed antibody screen on patient sample on (b)(6) 2017 in question with (b)(4) surgiscreen and a 2+ reaction against cell#1 (homozygous for fya) was observed, cell#2 and #3 were (b)(6).Customer reports antibody identification was performed with competitor's reagents and anti-fya was identified and showed dosage.Patient sample showed (b)(6) dat.Customer performed crossmatch with competitor's reagents and tube testing and incompatible results as expected were observed by customer against pos fya donors.Customer performed ahg crossmatch with sample in mts igg gel card lot# 031417001-56 against homozygous fya+ donor and compatible results were observed.Customer used mts diluent to create red cell suspension.Maintenance up to date.Tsc emailed customer crossmatch procedure and customer reports following procedure and now repeat testing revealed incompatible results.Tsc discussed possible low titer of antibody in testing plasma or antigen expression of fya antigen on the red cell could possibly cause the (b)(6) results.Customer requesting an investigation.Customer agreed to send sample in question, segments from donors and mts igg gel cards back to ortho for further investigation.Follow-up with customer indicated they still haven't shipped the material back to ortho yet.

• 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: 6862655
• MDR Text Key: 86318685
• Report Number: 1056600-2017-00074
• 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: 09/13/2017

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: 12/30/2017
• Device Catalogue Number: MTS84024
• Device Lot Number: 031417001-56
• Other Device ID Number: 10758750005994
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2017
• Initial Date FDA Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2017
• 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