MTS MTS084014Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10758750005987), received between Aug 25, 2023 and Aug 25, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2023False Negative Result; False Negative Result

  REPORT 4 OF 4. MXP2545163 RA602917 PROBLEM STATEMENT AND DESCRIPTION: CUSTOMER CONTACTED TSS VIA EMAIL REPORTING FALSE NEGATIVE POLY DAT ON VISION, DAT TESTING PERFORMED BY MANUAL TUBE WAS POSITIVE AND DAT TESTING AT REFERENCE LAB WAS POSITIVE. PATIENT HAD 4 SAMPLES COLLECTED AND RUN ON THE VISION WITH POLY DAT AS NEGATIVE: (B)(6) 2023: SAMPLE ID (B)(6) DAT POLY NEG (B)(6) 2023: SAMPLE ID (B)(6) DAT POLY NEG (B)(6) 2023: SAMPLE ID (B)(6) DAT POLY NEG (B)(6) 2023: SAMPLE ID (B)(6) DAT POLY NEG CUSTOMER SENT PATIENT SAMPLE TO REFERENCE LAB ON (B)(6) 2023 FOR DAT TESTING. RESULTS ARE POLY DAT:3+, MONO IGG DAT: 0 AND MONO C3 DAT: 3+. AUTOCOLD ANTIBODY. UNDERLYING ALLOANTIBODIES WERE EXCLUDED BY LISS-AHG TECHNIQUE. CUSTOMER REPEATED SAMPLE COLLECTED ON (B)(6) 2023 BY TUBE METHOD USING COMPETITOR ANTI-IGG,-C3D; POLYSPECIFIC (MURINE MONOCLONAL) RESULTS 3+ PATIENT WAS TRANSFUSED WITH 1 RBC ON (B)(6) 2023, 3 RBC'S ON (B)(6) 2023, AND 1 RBC ON (B)(6) 2023. ALL UNITS WERE TYPE SPECIFIC AND CROSSMATCH COMPATIBLE. CUSTOMER PROVIDED VISION ORDER REPORTS AND REFERENCE LAB REPORT. NEG QC AND POS QC FOR IGG PASSED FOR POLY GEL CARD EACH DAY OF USE. TSS DISCUSSED WITH CUSTOMER POLY GEL CARD QC SHOUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17627979 ↗
• MalfunctionAug 25, 2023False Negative Result; False Negative Result

  REPORT 2 OF 4. MXP2545163 RA602917 PROBLEM STATEMENT AND DESCRIPTION: CUSTOMER CONTACTED TSS VIA EMAIL REPORTING FALSE NEGATIVE POLY DAT ON VISION, DAT TESTING PERFORMED BY MANUAL TUBE WAS POSITIVE AND DAT TESTING AT REFERENCE LAB WAS POSITIVE. PATIENT HAD 4 SAMPLES COLLECTED AND RUN ON THE VISION WITH POLY DAT AS NEGATIVE: (B)(6) 2023: SAMPLE ID :(B)(6). DAT POLY NEG (B)(6) 2023: SAMPLE ID :(B)(6). DAT POLY NEG (B)(6) 2023: SAMPLE ID :(B)(6). DAT POLY NEG (B)(6) 2023: SAMPLE ID :(B)(6). DAT POLY NEG CUSTOMER SENT PATIENT SAMPLE TO REFERENCE LAB ON (B)(6) 2023 FOR DAT TESTING. RESULTS ARE POLY DAT:3+, MONO IGG DAT: 0 AND MONO C3 DAT: 3+. AUTOCOLD ANTIBODY. UNDERLYING ALLOANTIBODIES WERE EXCLUDED BY LISS-AHG TECHNIQUE. CUSTOMER REPEATED SAMPLE COLLECTED ON (B)(6) 2023 BY TUBE METHOD USING COMPETITOR ANTI-IGG,-C3D; POLYSPECIFIC (MURINE MONOCLONAL) RESULTS 3+ PATIENT WAS TRANSFUSED WITH 1 RBC ON (B)(6) 2023, 3 RBC'S ON (B)(6) 2023, AND 1 RBC ON (B)(6) 2023. ALL UNITS WERE TYPE SPECIFIC AND CROSSMATCH COMPATIBLE. CUSTOMER PROVIDED VISION ORDER REPORTS AND REFERENCE LAB REPORT. NEG QC AND POS QC FOR IGG PASSED FOR POLY GEL CARD EACH DAY OF USE. TSS DISCUSSED WITH CUSTOMER POLY GEL CARD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17627042 ↗
• MalfunctionAug 25, 2023False Negative Result; False Negative Result

  REPORT 3 OF 4. MXP2545163 RA602917 PROBLEM STATEMENT AND DESCRIPTION: CUSTOMER CONTACTED TSS VIA EMAIL REPORTING FALSE NEGATIVE POLY DAT ON VISION, DAT TESTING PERFORMED BY MANUAL TUBE WAS POSITIVE AND DAT TESTING AT REFERENCE LAB WAS POSITIVE. PATIENT HAD 4 SAMPLES COLLECTED AND RUN ON THE VISION WITH POLY DAT AS NEGATIVE: (B)(6) 2023: SAMPLE ID (B)(6). DAT POLY NEG (B)(6) 2023: SAMPLE ID (B)(6). DAT POLY NEG 7/13/23: SAMPLE ID (B)(6). DAT POLY NEG (B)(6) 2023: SAMPLE ID (B)(6). DAT POLY NEG CUSTOMER SENT PATIENT SAMPLE TO REFERENCE LAB ON (B)(6) 2023 FOR DAT TESTING. RESULTS ARE POLY DAT:3+, MONO IGG DAT: 0 AND MONO C3 DAT: 3+. AUTOCOLD ANTIBODY. UNDERLYING ALLOANTIBODIES WERE EXCLUDED BY LISS-AHG TECHNIQUE. CUSTOMER REPEATED SAMPLE COLLECTED ON 7/26/23 BY TUBE METHOD USING COMPETITOR ANTI-IGG,-C3D; POLYSPECIFIC (MURINE MONOCLONAL) RESULTS 3+ PATIENT WAS TRANSFUSED WITH 1 RBC ON (B)(6) 2023, 3 RBC'S ON (B)(6) 2023, AND 1 RBC ON (B)(6) 2023. ALL UNITS WERE TYPE SPECIFIC AND CROSSMATCH COMPATIBLE. CUSTOMER PROVIDED VISION ORDER REPORTS AND REFERENCE LAB REPORT. NEG QC AND POS QC FOR IGG PASSED FOR POLY GEL CARD EACH DAY OF USE. TSS DISCUSSED WITH CUSTOMER POLY GEL CARD QC SHOULD AL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17627000 ↗
• MalfunctionAug 25, 2023False Negative Result; False Negative Result

  REPORT 1 OF 4. MXP2545163 RA602917 PROBLEM STATEMENT AND DESCRIPTION: CUSTOMER CONTACTED TSS VIA EMAIL REPORTING FALSE NEGATIVE POLY DAT ON VISION, DAT TESTING PERFORMED BY MANUAL TUBE WAS POSITIVE AND DAT TESTING AT REFERENCE LAB WAS POSITIVE. PATIENT HAD 4 SAMPLES COLLECTED AND RUN ON THE VISION WITH POLY DAT AS NEGATIVE: (B)(6) 2023: SAMPLE ID :(B)(6) DAT POLY NEG (B)(6) 2023: SAMPLE ID :(B)(6) DAT POLY NEG (B)(6) 2023: SAMPLE ID (B)(6) DAT POLY NEG (B)(6) 2023: SAMPLE ID :(B)(6) DAT POLY NEG CUSTOMER SENT PATIENT SAMPLE TO REFERENCE LAB ON (B)(6) 2023 FOR DAT TESTING. RESULTS ARE POLY DAT:3+, MONO IGG DAT: 0 AND MONO C3 DAT: 3+. AUTOCOLD ANTIBODY. UNDERLYING ALLOANTIBODIES WERE EXCLUDED BY LISS-AHG TECHNIQUE. CUSTOMER REPEATED SAMPLE COLLECTED ON (B)(6) 2023 BY TUBE METHOD USING COMPETITOR ANTI-IGG,-C3D; POLYSPECIFIC (MURINE MONOCLONAL) RESULTS 3+ PATIENT WAS TRANSFUSED WITH 1 RBC ON (B)(6) 2023, 3 RBC'S ON (B)(6) 2023, AND 1 RBC ON (B)(6) 2023. ALL UNITS WERE TYPE SPECIFIC AND CROSSMATCH COMPATIBLE. CUSTOMER PROVIDED VISION ORDER REPORTS AND REFERENCE LAB REPORT. NEG QC AND POS QC FOR IGG PASSED FOR POLY GEL CARD EACH DAY OF USE. TSS DISCUSSED WITH CUSTOMER POLY GEL CARD QC SH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17626980 ↗