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 10/09/2018

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 reported discrepant results for patient rh typing between manual gel using mts gel and traditional tube method testing bio rad reagents.Also, testing was done with immucor reagents.Customer states that patient abo/rev typing on manual gel yields 2+ result on rh microtube, b positive blood type, while on manual tube method and using bio rad reagents, rh is negative and patient is typed as b-negative.Sample typed as b negative using immucor reagents on the immucor analyzer.Initial testing performed on ortho vision see (b)(4).Issue started on/tested on (b)(6) 2018, from one sample; reported (b)(6) 2018.Sample id: one patient.Microtubes/wells or cell (donor #) affected: rh well.Methodology used: vision, immucor and manual tube.Incubation time (for manual test only): as per ifu.Pattern observed: discrepant results.Reaction grade obtained: 2+ manual gel.Customer was expecting: matching results between 3 different methodologies.Other relevant details: first date of testing was (b)(6) 2018, first time patient, typed b-positive on vision analyzer.No previous history at this hospital, but history from another (b)(6) hospital was b negative.Patient typed b-negative in tube method when retyped.Vision types as b-positive, manual tube types as b-negative.All qc for reagents acceptable.Customer testing using abd/rev gel card lot# 050718037-69 on mts vision analyzer and manual gel.Tsc verified that "there was" only one patient sample was drawn and tested, results were accurate and reproduced both on vision analyzer and manual gel.Patient is typing rh positive on vision and manual gel, rh negative in tube method and with biorad reagents.Strength of positive reaction on vision analyzer has been 3+.Testing in manual gel has been 2+ positive.Weak-d testing done in tube was negative.Tsc discussed issue being isolated to patient, sample related, possible rh d variant.Tsc asked customer if they had sent samples to reference lab and customer said they did not.

• 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: 8015218
• MDR Text Key: 125657484
• Report Number: 1056600-2018-00175
• 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: 10/29/2018

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: No Information
• Device Expiration Date: 04/06/2019
• Device Catalogue Number: MTS080515
• Device Lot Number: 050718037-69
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/10/2018
• Initial Date FDA Received: 10/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2018
• 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