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 Problems False Positive Result (1227); Use of Device Problem (1670)

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

Event Date 02/22/2019

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 reporting false positive reactions in the anti-d microwell of mts abd/rev grouping cards lot # 110118037-02, exp 09/07/2019.Customer tested manually using ortho workstation on (b)(6) 2019.According to customer cards had low liquid level, but tech failed to check and used.However, no incorrect result released because the sample had a previous history of rh negative at facility.Customer further added that with repeat testing of sample using a "good card" from the same lot # that passed visual inspection and the same red cell suspension, saw negative reaction in the anti-d micro well.With further inspection, customer found one box of gel cards with low liquid levels.Foils intact.Will discard affected products and is requesting replacement.A second sample was tested on (b)(6) 2019.The second sample showed positive reactions in all the microwells (1+) which invalidates the results.Repeat testing using a "good card" was performed and the reactions were acceptable.Issue reported (b)(6) 2019.Microtubes/wells or cell (donor #) affected: anti-d microwell of gel card.Reaction grade obtained: 1- 2+.Customer was expecting: negative.Test repeated: yes.Method/result obtained by repeating: negative.Was qc affected? no.Product handling protocol: cassette/gel card storage temperature range: as per ifu.Rbc storage and handling: as per if.Visual appearance before use: low liquid levels in microwell.

• 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: 8417946
• MDR Text Key: 142502795
• Report Number: 1056600-2019-00009
• 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: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/07/2019
• Device Catalogue Number: MTS080515
• Device Lot Number: 110118037-02
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2018
• 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