MAUDE Adverse Event Report: MICROTYPING SYSTEMS BLOOD GROUPING REAGENT MTS A/B/D MONOCLONAL AND REVERSE GROUPING; 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 02/11/2019

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

Report 1 of 2.Customer contacting tsc to report 2 separate events of false positive mf reactions in the anti-a micro well to the mts abd/rev gel card on the ortho vison to a patient history know to be a blood group b pos.1st sample initially tested on (b)(6) 2019 at 17:46 and observed a mf reaction to the anti-a well in the mts abd/rev gel card.Remaining wells consistent of a blood group of b pos.Based on the forward and reverse typing discrepancy the sample the user then tested a second sample collected at the same time with the same barcode id and results again the same with a mf reaction to the anti-a well in the mts abd/rev gel card.Remaining wells consistent of a blood group of b pos.Repeat testing of the second sample performed on (b)(6) 2019 at 08:28 am.Mts abd/rev gel card lot# 092418001-07 used in testing.Customer initially repeated the blood group by tube and reports a clear b pos sample and negative against the anti-a antisera.Tsc discussed the possibility of dual cell populations existing in the sample, although unlikely that a b patient would be transfused red cells with the "a" antigen.Tsc advised the customer to repeat testing by tube and manual gel mimicking the way the vision probe would collect cells at the bottom of a packed cell sample.The customer has agreed to do so and the tsc followed up with the customer who reports weak agglutination by traditional tube and manual gel to the anti-a well.Customer has conclude that there are somehow red cells with a antigen in the sample.(b)(6), pregnant due for a c section.1st pregnancy, no dat performed customer indicates their confidence that the vison and the gel cards performed as intended and the concern is sample related.

• Brand Name: BLOOD GROUPING REAGENT MTS A/B/D MONOCLONAL AND REVERSE GROUPING
• 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: 8406475
• MDR Text Key: 138795934
• Report Number: 1056600-2019-00006
• Device Sequence Number: 1
• Product Code: KSZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/18/2019
• Device Catalogue Number: MTS080515
• Device Lot Number: 091418037-06
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2018
• 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