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 False Positive Result (1227)

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

Event Date 10/23/2018

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

Customer contacted tsc to report false positive result for patient abo front type testing with abd/rev gel card lot# 060618037-14, exp.01 may 2019 on manual bench testing.Customer states that historically known a-positive patient is yielding ab-positive front typing, anti-b microtube yielding 2+ result when it should be negative.Issue started on: (b)(6) 2018.Microtubes/wells or cell (donor #) affected: anti-b column.Methodology used: manual gel.Pattern observed: false positive result.Reaction grade obtained: 2+ reactivity.Customer was expecting: negative.Test repeated: yes.Result obtained by repeating: customer repeated testing using different diluent, issue persisted.Customer then repeated testing using alternate lot of abd/rev gel cards and issue was resolved.Method used to repeat: manual gel testing.Other relevant details: patient is historically known a-positive patient.All qc for reagents used was deemed acceptable.Only one patient sample was used for all testing.No erroneous results were reported out due to historical check and repeat testing using new lot of gel cards.Tsc verified that same sample was used for all testing.Customer performing testing according to ifu procedure.Alternate lot# of abd/rev gel cards has resolved the issue.

• 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: 8051454
• MDR Text Key: 128592938
• Report Number: 1056600-2018-00176
• 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: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/01/2019
• Device Catalogue Number: MTS080515
• Device Lot Number: 060618037-14
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2018
• 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