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 Known Impact Or Consequence To Patient (2692)

Event Date 10/04/2019

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 reporting one event of false positive result to a1 microwell of the reverse portion of mts abd/rev gel card with cap survey sample jat17 that had an expected result of group a positive.Testing performed using mts abd/rev card lot # 050119037-09 (exp 03.18.20) and 0.8% affirmagen lot # 8a024 (exp 10.22.19).Daily qc performed and acceptable (b)(6).Result of blood type from ortho provue showed the following result: anti-a= 4+; anti-b = 0; anti-d =3+ control =0; reverse a1-cell=1+ and reverse b -cell=3+.(forward as group a ; reverse as ab).Card was brought to review rack for review.Because of abo discrepancy, testing was repeated in provue the test repeated 10.08.19 gave the same results.Customer then tested sample in tube method and showed the abo group a positive with no issue.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.Troubleshooting steps performed by tsc: customer inquired if similar complaints were reported to ortho.

• 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: 9502407
• MDR Text Key: 219779492
• Report Number: 1056600-2019-00045
• 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: 03/18/2020
• Device Catalogue Number: MTS080515
• Device Lot Number: 050119037-09
• 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: 06/18/2019
• 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