MAUDE Adverse Event Report: MICROTYPING SYSTEMS ANTI-HUMAN GLOBULIN ANTI-IGG,-C3D POLYSPECIFIC (RABBIT) MTS¿ ANTI-IGG,-C3D CARD; MTS GEL CARDS- FOR DIRECT ANTIGLOBULIN TEST

Catalog Number MTS084014

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

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

Event Date 05/16/2017

Event Type  malfunction  

Manufacturer Narrative

Sample was returned to ortho for further investigation.Ortho performed retain and return testing, batch review, complaint review by lot and master lot.All results were satisfactory.(b)(4).

Event Description

Report 1 of 2.Customer reported a false negative result occurred with a dat done on a cord blood sample using poly gel cards lot# 013117005-01 exp.11/13/2017.Customer received a negative dat with the poly gel card and a positive 1+ dat reaction in tube using competitor's anti-igg reagent.Issue started on: (b)(6)2017.Frequency: 2x.Microtubes/wells or cell (donor #) affected: random microwell.Methodology used: manual gel.Reaction grade obtained: negative.Customer was expecting: positive.Test repeated: yes.Result obtained by repeating: negative.Method used to repeat: manual gel.Customer cells were packed and manually washed prior to testing.Card/cassette type: poly gel cards, lot number: 013117005-01, expire: 11-13-2017.Qc type: ortho confidence kit, qc lot #: not provided.Qc expiration date: not provided.Last qc run: (b)(6)2017.Sample type: edta.Visual appearance before use: acceptable.Pipette used: mts.Incubator type: mts.Cards/cassettes centrifugation: mts.Other relevant details: mother is a type 'o'.The baby is a type 'b'.The bilirubin was 14.8, with the baby under the bili-lights.Customer repeated the dat using the same lot of gel cards and received a negative reaction for the dat.Customer also tested the dat using mts anti-igg card, lot#101016001-06, exp.8/13/2017 with a false negative occurring with the dat (see (b)(4))customer reported she followed ifu procedure as follows: prepared a red blood cell suspension of approximately 0.8% in mts diluent 2 (e.G., deliver 1.0 ml of mts diluent 2 into a test tube and pipetted 10 ml packed red blood cells into the diluent), mix gently.Label the gel card appropriately.Remove the foil seal from the mts anti-igg,-c3d card or from the individual microtubes to be used for testing.After removing the foil, visually inspect all gel cards with no issues.Added 50 ml of the 0.8% dilution to each microtube.Customer centrifuged the prepared cards in the mts centrifuge.After centrifugation, removed the gel card (s) from the centrifuge.Observed, read macroscopically the front and back of each microtube for agglutination and/or hemolysis and record a negative reaction.Cts discussed with the customer that the hard spin of the tube reaction gave the weak reaction a 1+ dat using the immucor reagent.Customer is sending the sample to a reference lab for testing and she will call back to give update about the call.Customer called cts back to provide information on the sample eluate that the had anti-b.Customer will send a sample back to cts for further investigation.

• Brand Name: ANTI-HUMAN GLOBULIN ANTI-IGG,-C3D POLYSPECIFIC (RABBIT) MTS¿ ANTI-IGG,-C3D CARD
• Type of Device: MTS GEL CARDS- FOR DIRECT 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: marta carnielli ; 1001 route 202; raritan, NJ 08869 ; 9082188223
• MDR Report Key: 6612694
• MDR Text Key: 76959645
• Report Number: 1056600-2017-00048
• 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: 06/05/2017

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: 11/13/2017
• Device Catalogue Number: MTS084014
• Device Lot Number: 013117005-01
• Other Device ID Number: 10758750005994
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2017
• Initial Date FDA Received: 06/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2017
• 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