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

Catalog Number MTS080515

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

Ortho performed retain testing, batch review, complaint review by lot and master lot.Based upon the results of this investigation, the reported customer issue was unable to be confirmed.All results were satisfactory.Sample was not returned to ortho for further investigation.(b)(4).

Event Description

Account reports a patient with no previous history of abo type was tested on (b)(6) 2018 for first time and that typed as a pos in their facility; card lot 060717037-03 exp 04.21.18.Account has a policy to confirm abo type when they receive patients with no previous history of abo typing.So the same customer repeated testing in a different lot# of cards because she did not have more gel cards from the first lot#.Second time customer tested with a different card lot and that type as abpos.Due to the discrepant result customer repeated a third time with the different card lot this time the test had a control well positive so the test was invalidated.Account decided to send the specimen to a reference lab to resolve the abo discrepancy (b)(6).Issue started on: (b)(6) 2018.Reported 3-21-18.Microtubes/wells or cell (donor #) affected: abd typing.Methodology used: manual gel.Test repeated: yes - account received two different results daily qc performed and found to be acceptable with ortho confidence lot# cnf104 exp 04.10.18.Sample type: edta plasma.Cards /cassettes/rbc storage condition temperature: per ifu.Visual appearance before use: all reagents have a normal appearance prior to use.Customer will collect another sample.Also customer will switch to a different bottle of diluent 2 plus and will repeated testing with lot#101817037-06 of cards they have available.Follow up with customer to know the new results: customer switched to a new bottle of diluent 2 plus and repeated testing sample from (b)(6) 2018 the abo type was a positive sample from (b)(6) 2018 the abo type was a positive using card lot#101817037-06 customer reported satisfied with troubleshooting steps.No further actions need it by ortho at this time.

• Brand Name: BLOOD GROUPING REAGENT MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD
• 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: 7448267
• MDR Text Key: 106982863
• Report Number: 1056600-2018-00061
• 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: 04/20/2018

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: 09/06/2018
• Device Catalogue Number: MTS080515
• Device Lot Number: 101817037-06
• Other Device ID Number: 10758750005932
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2017
• 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