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 False Positive Result (1227); Incorrect Or Inadequate Test Results (2456)

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

Event Date 10/30/2017

Event Type  malfunction  

Manufacturer Narrative

Ortho performed retain testing, batch review, complaint review by lot and master lot.All results were satisfactory.Sample was requested for returned to ortho for further investigation.Return has not yet been received.(b)(4).

Event Description

Event 1 of 4.Account reports at least four newborn patient samples as having results between mixed field to 2+ positive reactions in the anti-b well that should be negative because the patients were tested again and they were classified as group o positive.Mts a/b/d/a/b/d mono and reverse lot# 060217053-02 exp 04.24.18.Diluent 2 plus and ortho confidence was used.Issue started on:(b)(6) 2017 reported (b)(6) 2017.Frequency: 4x.Microtubes/wells or cell (donor #) affected: anti-b.Methodology used: manual gel.Incubation time: 15 min.Daily qc has not been affected.Cards /cassettes/rbc storage condition temperature: refrigerated (as per ifu 2-25c) all reagents have a normal appearance prior to use.Sample was repeated and the result was o positive with a clear negative reaction in the anti-b well: 1.Cards did not show any signs of drying.2.Account does not know if sample contained any fibrin or not but they followed protocol with newborn samples and they wash rbc's 4x with saline before testing to avoid to have this issue.3.Samples were reconstituted in mts diluent 2 plus.Ortho recommend customer to switch to a new bottle of diluent 2 plus because customer only has the same lot#, customer thinks that the diluent is not the problem because they run a daily control for the diluent and the diluent control was negative yesterday.Customer cleans the dispenser weekly.Customer is going to repeat testing but customer thinks the gel cards are the issue.Customer does not have a different lot# of gel cards and request replacement of two boxes.Ortho will send a different lot number of gel cards for troubleshooting purposes.Customer sent a picture to ortho for analysis of one of the test that was run (b)(6)2017 and repeated (b)(6) 2017.Image attached to the complaint.The customer has agreed to call back if not resolved.Customer called back to obtain status of complaint.Tsc informed customer that package has been sent to obtain return product.

• 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: 7045443
• MDR Text Key: 93724319
• Report Number: 1056600-2017-00096
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 11/20/2017

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: 04/24/2018
• Device Catalogue Number: MTS081115
• Device Lot Number: 060217053-02
• Other Device ID Number: 10758750005963
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2017
• 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