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

Catalog Number MTS081115

Device Problems Incorrect Or Inadequate Test Results (2456); Incorrect Device Or Component Shipped (2962)

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

Event Date 02/26/2018

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.Remaining customer gel cards were returned to ortho for further investigation.Returned cards containing the appropriate liquid levels performed as expected.(b)(4).

Event Description

Report 19 of 29.Account has one box of abd/abd cards lot 081117053-04 that they received on 1-18-2018 and the a and b typings are not correct.Sometimes they get false positive, sometimes false negatives (i.E ab is testing as o, o is testing as ab).D typings are fine.Account only uses cards for donor retypes and this is the only box they have.Account is now doing donor retypes on abd/reverse cards without any problems.Issue started on: reported (b)(6) 2018.Frequency: multiple times ; approximately 29 gel cards.Microtubes/wells or cell (donor #) affected: only the forward a and b microtubes.D typings not affected.Methodology used: manual gel.Reaction grade obtained: sometimes false positive, sometimes false negative.Customer was expecting: results to be accurate.Daily qc was performed today with no problem.Sample type: donor units.Cards /cassettes/ storage condition temperature: per ifu.Visual appearance before use: all reagents have a normal appearance prior to use.Image of an unused card was obtained and image will be attached.Account has switched to abd/reverse cards and problem has been eliminated.Will issue rga to get cards back.Will replace one box of cards.

• Brand Name: BLOOD GROUPING REAGENT MTS¿ A/B/D MONOCLONAL 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: 7351233
• MDR Text Key: 103277152
• Report Number: 1056600-2018-00025
• 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: 03/19/2018

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: 09/05/2018
• Device Catalogue Number: MTS081115
• Device Lot Number: 081117053-04
• Other Device ID Number: 10758750005963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2018
• Initial Date FDA Received: 03/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2017
• 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