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 False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2019

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

Report 1 of 2.One patient with a previous history of rh negative using tube typing, typed rh positive on the vision using mts card lot# 072318037-68.(site contact not aware if weak d testing was performed) account had another sample drawn and testing demonstrated the same false positive results.Account sent the sample to the arc who also performed testing in tube with weak d testing and determined the sample to be rh negative.No harm came to the patient.Account will only selected rh negative cells for possible transfusion.Reported (b)(6) 2019.Microtubes/wells or cell (donor #) affected: d microtube.Reaction grade obtained: 2+.Customer was expecting: negative.Incubation time (for manual test only): na.Test repeated: yes - on a new sample and by sending sample to a reference lab.Method/result obtained by repeating: new sample at this lab - still 2+.Reference lab negative including weak d testing.Daily qc performed and found to be acceptable.Product handling protocol: cassette/gel card storage temperature range: per ifu.Cassette/gel card orientation: upright.Rbc storage and handling: per ifu.Visual appearance before use: all reagents have a normal appearance prior to use.Opened vs unopened? opened.Tsc: informed account about the differences in product clones and how this may account for the discrepancy.In addition, inadequate centrifugation of the sample may cause the presence of fibrin and/or cellular debris.

• 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: 8582348
• MDR Text Key: 201891694
• Report Number: 1056600-2019-00017
• 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: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/03/2019
• Device Catalogue Number: MTS080515
• Device Lot Number: 072318037-68
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2018
• 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