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 Reaction (2414)

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

Batch record review, complaint review and retained testing were completed.Based upon the results of this investigation, the reported customer issue was unable to be confirmed.(b)(4).

Event Description

Customer performed blood grouping test on the provue on cap sample id# jat-17 using abd/reverse card lot 031519037-18 and 0.8% affirmagen cells lot 8a014 exp 10/22/19.A false positive 1+ backtype reaction was obtained in the buffered well with the affirmagen a cell.The expected result was a pos based on the cap answer key but the customer reported no blood group type could be determined with a note that additional testing would be required.This was due to the false positive 1+ reaction.The antibody screen that was also done on the sample in question was positive.No antibody identification testing was performed but the answer key showed sample jat-17 was a pos, with an anti-c.Customer does not suspect the provue produced wrong result and agreed with the 1+ grading.Qc and other patient samples have been passing with no issues.Relevant information: - issue started on: (b)(6) 2019.- microtubes/wells or cell (donor #) affected: buffered well #5.- reaction grade obtained: 1+.- customer was expecting: neg.- test repeated: no.- number of samples affected? one cap sample only, all other tests were as expected - was qc affected? no, qc passed.Product handling protocol:: - cassette/gel card storage temperature range: as per ifu.- cassette/gel card orientation: acceptable.- rbc storage and handling: as per ifu.- visual appearance before use: acceptable.- opened vs unopened? opened.- other relevant information: none.Actions already performed by contact: none, sample was too old for additional testing when answer key was made available by cap.The concern is isolated to the cap sample.

• 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: james a stevens ; 1001 route 202; raritan, NJ 08869 ; 9082188223
• MDR Report Key: 9502397
• MDR Text Key: 221009504
• Report Number: 1056600-2019-00044
• 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: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/16/2020
• Device Catalogue Number: MTS080515
• Device Lot Number: 031519037-18
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2019
• 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