MAUDE Adverse Event Report: MICROTYPING SYSTEMS BLOOD GROUPING REAGENT MTS A/B/D MONOCLONAL AND REVERSE GROUPING; MTS GEL CARDS - BLOOD GROUPING REAGENTS

Catalog Number MTS080515

Device Problems False Positive Result (1227); Incorrect Or Inadequate Test Results (2456)

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

Event Date 10/15/2017

Event Type  malfunction  

Manufacturer Narrative

Ortho performed retain testing, batch review, complaint review by lot and master lot.All results were satisfactory.Sample was requested for return but as of date of reportability, has not been returned to ortho for further investigation.(b)(4).

Event Description

3 of 4 reports.Customer reporting qc failing and false positive reactions noted with both qc samples and random patients testing using mts abd/rev grouping cards lot # 070717037-02 exp 6/5/2018, foward testing.According to customer, the gel card lot was first put into use on (b)(6) 2017, and site started to see samples with known blood types falsely reacting with the anti-b microtube for example, customer claimed that patients with previous history of group a, rh positive, they noticed positive reactions in the anti-b microtube.( 1-3+ positive).Customer stated because of previous history, all testing was repeated using the mts abd/abd monoclonal gel cards lot # 041917053-03 and the anti-b microtube reactions were negative.Customer is reporting similar false positive reactions during qc testing using ortho confidence kiit # (b)(4).Indicated qc is failing where site is getting false positive anti-b reactions with vial #2.Customer also added that in a few cases, the control well is reacting positive using the same lot # of cards.No erroneous results were reported.All testing was repeated using a combination of mts abd/abd gel cards and tube methods to confirm blood types of patients, so no errorenous results reported.Issue started on: (b)(6) 2017; reported (b)(6) 2017.Frequency: 4x for false positive in forward grouping anti-b microtube; 5x for false positive in control microtube.Trend: random microwells of gel cards are reacting positive.Methodology used: manual gel.Incubation time (for manual test only): 15 min.Associated reagents: mts diluent 2+ lot # mdp149 exp 5/30/2018; ortho confidence kit # cnf081 exp 10/24/2017 patient/sample data: edta.Cards /cassettes/ storage condition temperature: as per ifu visual appearance before use: acceptable.Customer repeated testing by tube method and all reactions gave expected results based on patient history.Tsc reviewed the procedure with the customer to remove the card foil properly to prevent carry over, but customer does not believe this is the issue.Customer claimed all gel cards were inspected prior to testing and were passing visual inspection.Foils intact.Tsc also discuss with the customer the status of appearance of the diluent and was told that the diluent appearance is acceptable.Customer stated that site pours out a small volume of diluent 2+ daily for used and stored the remaining bottle at 2-8c.Customer stated that when testing was repeated using alternative methods, customer was getting the correct results; however, customer is concerned with the unexpected positive results noted in the anti-b microwell of the gel cards ( foward portion) and in a few cases the control well reacting positive.Tsc will send an alternative lot # to assist in troubleshooting customer called back stating that replacement lot # 070717037-11 exp 6/17/2018 is getting acceptable results.Customer is requesting an additional three sets of gel cards.Tsc sent copy of destruction letter for customer to discard affected products.

• Brand Name: BLOOD GROUPING REAGENT MTS A/B/D MONOCLONAL AND REVERSE GROUPING
• Type of Device: MTS GEL CARDS - BLOOD GROUPING REAGENTS
• 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: 7034157
• MDR Text Key: 93345471
• Report Number: 1056600-2017-00094
• 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: 11/15/2017

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: 06/05/2018
• Device Catalogue Number: MTS080515
• Device Lot Number: 070717037-02
• Other Device ID Number: 10758750005932
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2017
• 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