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 Consequences Or Impact To Patient (2199)

Event Date 02/28/2018

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 an ob patient that typed as o pos by their facility on (b)(6) 2018 using mts abd/rev card lot# 071717037-66.D typing was 1+.Account has a policy that if the d typing is 3+ or less, they have to send it to a reference lab.The same day, they sent the sample (different tube but same time of draw) to a reference lab that claimed to also use gel technology, and they received rh negative results.Weak d testing was not done.Account will treat the patient as rh negative as d typing was for possible rh immune globulin administration.However, yesterday they still had a little bit of the original sample tube in which they tested and repeated using mts abd/rev lot# 121517037-51 (see mxp 1995397).Once again they received 1+ results for the d typing.Sample was nearly depleted and hemolyzed so account discarded it.Issue started on:(b)(6) 2018.Reported 3-8-2018.Microtubes/wells or cell (donor #) affected: d typing.Methodology used: manual gel.Reaction grade obtained: 1+.Customer was expecting: account is not sure.Test repeated: yes - account received 1+ again on another lot of cards but reference lab called in negative in gel.Qc data: daily qc performed and found to be acceptable.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.Account treating patient as if they were rh negative and administering rh immune globulin.No harm came to patient.

• 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: 7389506
• MDR Text Key: 104674091
• Report Number: 1056600-2018-00049
• 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: 04/02/2018

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: 05/17/2018
• Device Catalogue Number: MTS080515
• Device Lot Number: 071717037-66
• Other Device ID Number: 10758750005932
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2018
• Initial Date FDA Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2017
• 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