PFA-100® System 10444868Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00842768024870), received between Jul 16, 2018 and Sep 20, 2021 — classified as 29 malfunctions.

The most frequently reported specific device problem is “High Test Results” (24 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2021High Test Results; High Test Results

  TWO DISCORDANT, FALSELY ELEVATED PLATELET FUNCTION ASSAY COLLAGEN-EPINEPHRINE (PFA COL EPI) RESULTS AND TWO DISCORDANT, FALSELY ELEVATED PLATELET FUNCTION ASSAY COLLAGEN-ADENOSINE DIPHOSPHATE (PFA COL ADP) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A PFA-100 SYSTEM (SERIAL NUMBER: 2174). THE RESULTS WERE FLAGGED WITH "MAXIMUM TEST TIME EXCEEDED" FLAGS. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). A NEW SAMPLE FROM THE SAME PATIENT WAS RUN FOR PFA COL EPI AND PFA COL ADP ON AN ALTERNATE PFA-100 SYSTEM, BOTH RESULTING LOWER. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). A DISCORDANT, FALSELY ELEVATED PFA COL EPI RESULT AND A DISCORDANT, FALSELY ELEVATED PFA COL ADP RESULT WERE OBTAINED ON ANOTHER SAMPLE FROM A DIFFERENT PATIENT. THE RESULTS WERE FLAGGED WITH "MAXIMUM TEST TIME EXCEEDED" FLAGS. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED FOR PFA COL EPI AND PFA COL ADP ON AN ALTERNATE PFA-100 SYSTEM, BOTH RESULTING LOWER. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12497059 ↗
• MalfunctionAug 16, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A DISCORDANT, FALSELY ELEVATED PLATELET FUNCTION ASSAY COLLAGEN-EPINEPHRINE (PFA COL EPI) RESULT AND A DISCORDANT, FALSELY LOW PLATELET FUNCTION ASSAY COLLAGEN-ADENOSINE DIPHOSPHATE (PFA COL ADP) RESULT WERE OBTAINED ON A PATIENT SAMPLE ON A PFA-100 SYSTEM. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FOR PFA COL EPI AND PFA COL ADP ON AN ALTERNATE PFA-100 SYSTEM. THE PFA COL EPI RECOVERED LOWER AND THE PFA COL ADP RECOVERED HIGHER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PFA COL EPI AND PFA COL ADP RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12328589 ↗
• MalfunctionJun 4, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT ADENOSINE DIPHOSPHATE (ADP) CARTRIDGES WERE INTERMITTENTLY BEING READ AS EPINEPHRINE (EPI) ON THEIR PFA-100 SYSTEM. NO DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE CUSTOMER REPEATED THE AFFECTED SAMPLES WITH A NEW ADP CARTRIDGE AND REPORTED OUT THESE REPEAT RESULTS, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10119745 ↗
• MalfunctionDec 13, 2019Non Reproducible Results; Non Reproducible Results

  ON (B)(6) 2019, INCONSISTENT PLATELET FUNCTION ASSAY (PFA) - EPINEPHRINE (EPI) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A PFA-100 SYSTEM (SN:(B)(4)) USING THE EPI (LOT#5695478) REAGENT CARTRIDGE. THE SAMPLE WAS INITIALLY SPLIT BETWEEN TWO TUBES AND BOTH TUBES WERE TESTED FOR EPI RESULTING ABOVE THE LAB'S NORMAL REFERENCE RANGE. ONLY THE SECOND TUBE WAS TESTED FOR ADENOSINE DIPHOSPHATE (ADP) RESULTING ABOVE THE LAB'S NORMAL REFERENCE RANGE. THE SAMPLES WERE SENT TO AN ALTERNATE LAB FOR REPEAT TESTING OF BOTH EPI AND ADP, AND THE RESULTS WERE ALSO ABOVE THE LAB'S NORMAL REFERENCE RANGE. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE RESULTS OBTAINED FROM THE ALTERNATE LAB WERE REPORTED TO THE PHYSICIAN(S) AS CORRECT. ADP RESULT WAS NOT REPORTED AS INCONSISTENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE INCONSISTENT EPI RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9469173 ↗
• MalfunctionNov 19, 2019High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED PLATELET FUNCTION ASSAY (PFA) - COLLAGEN EPINEPHRINE (COL/EPI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A PFA-100 SYSTEM USING COLLAGEN EPINEPHRINE REAGENT. THIS RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS THEN REPEATED FOR PFA - COL/EPI ON AN ALTERNATE PFA-100 SYSTEM (SERIAL NUMBER (B)(4)), RESULTING LOWER. THE SAME SAMPLE WAS THEN REPEATED AGAIN FOR PFA - COL/EPI ON THE INITIAL PFA-100 SYSTEM ALSO RESULTING LOWER AND CONFIRMING THE OTHER REPEAT RESULT. THE REPEAT RESULT OBTAINED ON THE ALTERNATE PFA-100 SYSTEM WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED PLATELET FUNCTION ASSAY (PFA) - COLLAGEN EPINEPHRINE (COL/EPI) RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9341276 ↗
• MalfunctionJan 4, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER INDICATED THAT DURING A TWO WEEK PERIOD, FLAGGED COLLAGEN/ EPINEPHRINE (COL/EPI) AND COLLAGEN/ADENOSINE-5'-DIPHOSPHATE (COL/ADP) RESULTS WERE OBTAINED ON FOUR PATIENT SAMPLES ON A PFA-100 SYSTEM. THE CUSTOMER REPORTED THESE RESULTS AS ">300 SECONDS" TO THE PHYSICIAN (S) AND BASED ON THESE RESULTS, THE PATIENTS WERE TRANSFUSED WITH PLATELETS. THE PATIENTS WERE SENT TO AN ALTERNATE LABORATORY, WHERE THEIR BLOOD WAS REDRAWN. THE NEW SAMPLES WERE RUN AT THE ALTERNATE LABORATORY AND THE RESULTS RECOVERED WITHIN NORMAL RANGES. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO FLAGGED COL/EPI AND COL/ADP RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8216954 ↗
• MalfunctionDec 14, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2018, THE CUSTOMER REPORTED THAT DIFFERENT COLLAGEN/EPINEPHRINE (COL/EPI) AND COLLAGEN/ADENOSINE-5'-DIPHOSPHATE (COL/ADP) RESULTS WERE OBTAINED ON SEVERAL PATIENT SAMPLES WHEN PATIENT SAMPLES WERE RUN IN DUPLICATE ON THE PFA-100 SYSTEM. THE CUSTOMER REPORTED THAT "NORMAL RESULTS" WERE OBTAINED ON THE SAMPLES WHEN THE SAMPLES WERE RUN IN POSITION A, WHILE "GREATER THAN (>) RESULTS WITH ERRORS" WERE OBTAINED ON THE SAMPLES WHEN THE SAMPLES WERE RUN IN POSITION B. THE CUSTOMER DID NOT SPECIFY THE ERRORS THAT WERE OBTAINED WHEN THE SAMPLES WERE RUN IN POSITION B. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER DID NOT PROVIDE THE PATIENT DATA. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENT COL/EPI AND COL/ADP RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8164796 ↗
• MalfunctionAug 31, 2018High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED COLLAGEN/EPINEPHRINE (COL/EPI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A PFA-100 SYSTEM. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME SYSTEM, RESULTING LOWER. IT IS UNKNOWN IF THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE CUSTOMER REPORTED THAT DISCORDANT, FALSELY ELEVATED COL/EPI RESULTS OF >300 SECONDS WERE OBTAINED ON OTHER PATIENT SAMPLES. WHEN THE SAMPLES WERE REPEATED ON THE SAME SYSTEM, LOWER RESULTS WERE OBTAINED. THE CUSTOMER REPORTED THE LOWER RESULTS TO THE PHYSICIAN(S). THE CUSTOMER DID NOT PROVIDE DATA FOR ALL PATIENTS IMPACTED BY THIS EVENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED COL/EPI RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7839623 ↗
• MalfunctionAug 31, 2018High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED COLLAGEN/EPINEPHRINE (COL/EPI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A PFA-100 SYSTEM. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME SYSTEM AND THE SAME RESULT WAS OBTAINED. IT IS UNKNOWN IF THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE CUSTOMER REPORTED THAT DISCORDANT, FALSELY ELEVATED COL/EPI RESULTS OF >300 SECONDS WERE OBTAINED ON OTHER PATIENT SAMPLES. WHEN THE SAMPLES WERE REPEATED ON THE SAME SYSTEM, LOWER RESULTS WERE OBTAINED. THE CUSTOMER REPORTED THE LOWER RESULTS TO THE PHYSICIAN(S). THE CUSTOMER DID NOT PROVIDE DATA FOR ALL PATIENTS IMPACTED BY THIS EVENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED COL/EPI RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7839620 ↗
• MalfunctionAug 31, 2018High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED COLLAGEN/EPINEPHRINE (COL/EPI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A PFA-100 SYSTEM. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED THREE TIMES ON THE SAME SYSTEM, RESULTING LOWER. THE 2ND REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE CUSTOMER REPORTED THAT DISCORDANT, FALSELY ELEVATED COL/EPI RESULTS OF >300 SECONDS WERE OBTAINED ON OTHER PATIENT SAMPLES. WHEN THE SAMPLES WERE REPEATED ON THE SAME SYSTEM, LOWER RESULTS WERE OBTAINED. THE CUSTOMER REPORTED THE LOWER RESULTS TO THE PHYSICIAN(S). THE CUSTOMER DID NOT PROVIDE DATA FOR ALL PATIENTS IMPACTED BY THIS EVENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED COL/EPI RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7839618 ↗
• MalfunctionAug 31, 2018High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED COLLAGEN/EPINEPHRINE (COL/EPI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A PFA-100 SYSTEM. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME SYSTEM, RESULTING LOWER. IT IS UNKNOWN IF THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE CUSTOMER REPORTED THAT DISCORDANT, FALSELY ELEVATED COL/EPI RESULTS OF >300 SECONDS WERE OBTAINED ON OTHER PATIENT SAMPLES. WHEN THE SAMPLES WERE REPEATED ON THE SAME SYSTEM, LOWER RESULTS WERE OBTAINED. THE CUSTOMER REPORTED THE LOWER RESULTS TO THE PHYSICIAN(S). THE CUSTOMER DID NOT PROVIDE DATA FOR ALL PATIENTS IMPACTED BY THIS EVENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED COL/EPI RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7839617 ↗
• MalfunctionAug 31, 2018High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED COLLAGEN/EPINEPHRINE (COL/EPI) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON A PFA-100 SYSTEM. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME SYSTEM, RESULTING LOWER. IT IS UNKNOWN IF THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE CUSTOMER REPORTED THAT DISCORDANT, FALSELY ELEVATED COL/EPI RESULTS OF >300 SECONDS WERE OBTAINED ON OTHER PATIENT SAMPLES. WHEN THE SAMPLES WERE REPEATED ON THE SAME SYSTEM, LOWER RESULTS WERE OBTAINED. THE CUSTOMER REPORTED THE LOWER RESULTS TO THE PHYSICIAN(S). THE CUSTOMER DID NOT PROVIDE DATA FOR ALL PATIENTS IMPACTED BY THIS EVENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED COL/EPI RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7839616 ↗
• MalfunctionAug 31, 2018High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED COLLAGEN/EPINEPHRINE (COL/EPI) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A PFA-100 SYSTEM. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME SYSTEM, RESULTING LOWER. IT IS UNKNOWN IF THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE CUSTOMER REPORTED THAT DISCORDANT, FALSELY ELEVATED COL/EPI RESULTS OF >300 SECONDS WERE OBTAINED ON OTHER PATIENT SAMPLES. WHEN THE SAMPLES WERE REPEATED ON THE SAME SYSTEM, LOWER RESULTS WERE OBTAINED. THE CUSTOMER REPORTED THE LOWER RESULTS TO THE PHYSICIAN(S). THE CUSTOMER DID NOT PROVIDE DATA FOR ALL PATIENTS IMPACTED BY THIS EVENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED COL/EPI RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7839615 ↗
• MalfunctionJul 16, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT ELEVATED COLLAGEN/ EPINEPHRINE (COL/EPI) AND COLLAGEN/ ADENOSINE-5'-DIPHOSPHATE (COL/ADP) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON THE PFA-100 SYSTEM FOR SEVERAL DAYS. THE ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND SOME PHYSICIAN(S) QUESTIONED THE ELEVATED RESULTS. IT IS UNKNOWN IF THE RESULTS PROVIDED BY THE CUSTOMER WERE DISCORDANT AND THE RESULTS REPORTED TO THE PHYSICIAN(S) ARE UNKNOWN. THE CUSTOMER DID NOT PROVIDE THE CORRECT RESULTS FOR THE PATIENTS IMPACTED AND REPORTED THAT THEY DID NOT PROVIDE CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO ELEVATED COL/EPI AND COL/ADP RESULTS OBTAINED ON THE PATIENT SAMPLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7689201 ↗
• MalfunctionJul 16, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT ELEVATED COLLAGEN/ EPINEPHRINE (COL/EPI) AND COLLAGEN/ ADENOSINE-5'-DIPHOSPHATE (COL/ADP) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON THE PFA-100 SYSTEM FOR SEVERAL DAYS. THE ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND SOME PHYSICIAN(S) QUESTIONED THE ELEVATED RESULTS. IT IS UNKNOWN IF THE RESULTS PROVIDED BY THE CUSTOMER WERE DISCORDANT AND THE RESULTS REPORTED TO THE PHYSICIAN(S) ARE UNKNOWN. THE CUSTOMER DID NOT PROVIDE THE CORRECT RESULTS FOR THE PATIENTS IMPACTED AND REPORTED THAT THEY DID NOT PROVIDE CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO ELEVATED COL/EPI AND COL/ADP RESULTS OBTAINED ON THE PATIENT SAMPLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7689198 ↗
• MalfunctionJul 16, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT ELEVATED COLLAGEN/ EPINEPHRINE (COL/EPI) AND COLLAGEN/ ADENOSINE-5'-DIPHOSPHATE (COL/ADP) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON THE PFA-100 SYSTEM FOR SEVERAL DAYS. THE ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND SOME PHYSICIAN(S) QUESTIONED THE ELEVATED RESULTS. IT IS UNKNOWN IF THE RESULTS PROVIDED BY THE CUSTOMER WERE DISCORDANT AND THE RESULTS REPORTED TO THE PHYSICIAN(S) ARE UNKNOWN. THE CUSTOMER DID NOT PROVIDE THE CORRECT RESULTS FOR THE PATIENTS IMPACTED AND REPORTED THAT THEY DID NOT PROVIDE CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO ELEVATED COL/EPI AND COL/ADP RESULTS OBTAINED ON THE PATIENT SAMPLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7689197 ↗
• MalfunctionJul 16, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT ELEVATED COLLAGEN/ EPINEPHRINE (COL/EPI) AND COLLAGEN/ ADENOSINE-5'-DIPHOSPHATE (COL/ADP) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON THE PFA-100 SYSTEM FOR SEVERAL DAYS. THE ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND SOME PHYSICIAN(S) QUESTIONED THE ELEVATED RESULTS. IT IS UNKNOWN IF THE RESULTS PROVIDED BY THE CUSTOMER WERE DISCORDANT AND THE RESULTS REPORTED TO THE PHYSICIAN(S) ARE UNKNOWN. THE CUSTOMER DID NOT PROVIDE THE CORRECT RESULTS FOR THE PATIENTS IMPACTED AND REPORTED THAT THEY DID NOT PROVIDE CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO ELEVATED COL/EPI AND COL/ADP RESULTS OBTAINED ON THE PATIENT SAMPLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7689196 ↗
• MalfunctionJul 16, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT ELEVATED COLLAGEN/ EPINEPHRINE (COL/EPI) AND COLLAGEN/ ADENOSINE-5'-DIPHOSPHATE (COL/ADP) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON THE PFA-100 SYSTEM FOR SEVERAL DAYS. THE ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND SOME PHYSICIAN(S) QUESTIONED THE ELEVATED RESULTS. IT IS UNKNOWN IF THE RESULTS PROVIDED BY THE CUSTOMER WERE DISCORDANT AND THE RESULTS REPORTED TO THE PHYSICIAN(S) ARE UNKNOWN. THE CUSTOMER DID NOT PROVIDE THE CORRECT RESULTS FOR THE PATIENTS IMPACTED AND REPORTED THAT THEY DID NOT PROVIDE CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO ELEVATED COL/EPI AND COL/ADP RESULTS OBTAINED ON THE PATIENT SAMPLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7689195 ↗
• MalfunctionJul 16, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT ELEVATED COLLAGEN/ EPINEPHRINE (COL/EPI) AND COLLAGEN/ ADENOSINE-5'-DIPHOSPHATE (COL/ADP) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON THE PFA-100 SYSTEM FOR SEVERAL DAYS. THE ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND SOME PHYSICIAN(S) QUESTIONED THE ELEVATED RESULTS. IT IS UNKNOWN IF THE RESULTS PROVIDED BY THE CUSTOMER WERE DISCORDANT AND THE RESULTS REPORTED TO THE PHYSICIAN(S) ARE UNKNOWN. THE CUSTOMER DID NOT PROVIDE THE CORRECT RESULTS FOR THE PATIENTS IMPACTED AND REPORTED THAT THEY DID NOT PROVIDE CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO ELEVATED COL/EPI AND COL/ADP RESULTS OBTAINED ON THE PATIENT SAMPLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7689193 ↗
• MalfunctionJul 16, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT ELEVATED COLLAGEN/ EPINEPHRINE (COL/EPI) AND COLLAGEN/ ADENOSINE-5'-DIPHOSPHATE (COL/ADP) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON THE PFA-100 SYSTEM FOR SEVERAL DAYS. THE ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND SOME PHYSICIAN(S) QUESTIONED THE ELEVATED RESULTS. IT IS UNKNOWN IF THE RESULTS PROVIDED BY THE CUSTOMER WERE DISCORDANT AND THE RESULTS REPORTED TO THE PHYSICIAN(S) ARE UNKNOWN. THE CUSTOMER DID NOT PROVIDE THE CORRECT RESULTS FOR THE PATIENTS IMPACTED AND REPORTED THAT THEY DID NOT PROVIDE CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO ELEVATED COL/EPI AND COL/ADP RESULTS OBTAINED ON THE PATIENT SAMPLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7689192 ↗
• MalfunctionJul 16, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT ELEVATED COLLAGEN/ EPINEPHRINE (COL/EPI) AND COLLAGEN/ ADENOSINE-5'-DIPHOSPHATE (COL/ADP) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON THE PFA-100 SYSTEM FOR SEVERAL DAYS. THE ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND SOME PHYSICIAN(S) QUESTIONED THE ELEVATED RESULTS. IT IS UNKNOWN IF THE RESULTS PROVIDED BY THE CUSTOMER WERE DISCORDANT AND THE RESULTS REPORTED TO THE PHYSICIAN(S) ARE UNKNOWN. THE CUSTOMER DID NOT PROVIDE THE CORRECT RESULTS FOR THE PATIENTS IMPACTED AND REPORTED THAT THEY DID NOT PROVIDE CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO ELEVATED COL/EPI AND COL/ADP RESULTS OBTAINED ON THE PATIENT SAMPLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7689191 ↗
• MalfunctionJul 16, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT ELEVATED COLLAGEN/ EPINEPHRINE (COL/EPI) AND COLLAGEN/ ADENOSINE-5'-DIPHOSPHATE (COL/ADP) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON THE PFA-100 SYSTEM FOR SEVERAL DAYS. THE ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND SOME PHYSICIAN(S) QUESTIONED THE ELEVATED RESULTS. IT IS UNKNOWN IF THE RESULTS PROVIDED BY THE CUSTOMER WERE DISCORDANT AND THE RESULTS REPORTED TO THE PHYSICIAN(S) ARE UNKNOWN. THE CUSTOMER DID NOT PROVIDE THE CORRECT RESULTS FOR THE PATIENTS IMPACTED AND REPORTED THAT THEY DID NOT PROVIDE CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO ELEVATED COL/EPI AND COL/ADP RESULTS OBTAINED ON THE PATIENT SAMPLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7689190 ↗
• MalfunctionJul 16, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT ELEVATED COLLAGEN/ EPINEPHRINE (COL/EPI) AND COLLAGEN/ ADENOSINE-5'-DIPHOSPHATE (COL/ADP) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON THE PFA-100 SYSTEM FOR SEVERAL DAYS. THE ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND SOME PHYSICIAN(S) QUESTIONED THE ELEVATED RESULTS. IT IS UNKNOWN IF THE RESULTS PROVIDED BY THE CUSTOMER WERE DISCORDANT AND THE RESULTS REPORTED TO THE PHYSICIAN(S) ARE UNKNOWN. THE CUSTOMER DID NOT PROVIDE THE CORRECT RESULTS FOR THE PATIENTS IMPACTED AND REPORTED THAT THEY DID NOT PROVIDE CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO ELEVATED COL/EPI AND COL/ADP RESULTS OBTAINED ON THE PATIENT SAMPLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7689189 ↗
• MalfunctionJul 16, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT ELEVATED COLLAGEN/ EPINEPHRINE (COL/EPI) AND COLLAGEN/ ADENOSINE-5'-DIPHOSPHATE (COL/ADP) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON THE PFA-100 SYSTEM FOR SEVERAL DAYS. THE ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND SOME PHYSICIAN(S) QUESTIONED THE ELEVATED RESULTS. IT IS UNKNOWN IF THE RESULTS PROVIDED BY THE CUSTOMER WERE DISCORDANT AND THE RESULTS REPORTED TO THE PHYSICIAN(S) ARE UNKNOWN. THE CUSTOMER DID NOT PROVIDE THE CORRECT RESULTS FOR THE PATIENTS IMPACTED AND REPORTED THAT THEY DID NOT PROVIDE CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO ELEVATED COL/EPI AND COL/ADP RESULTS OBTAINED ON THE PATIENT SAMPLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7689187 ↗
• MalfunctionJul 16, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT ELEVATED COLLAGEN/ EPINEPHRINE (COL/EPI) AND COLLAGEN/ ADENOSINE-5'-DIPHOSPHATE (COL/ADP) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON THE PFA-100 SYSTEM FOR SEVERAL DAYS. THE ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND SOME PHYSICIAN(S) QUESTIONED THE ELEVATED RESULTS. IT IS UNKNOWN IF THE RESULTS PROVIDED BY THE CUSTOMER WERE DISCORDANT AND THE RESULTS REPORTED TO THE PHYSICIAN(S) ARE UNKNOWN. THE CUSTOMER DID NOT PROVIDE THE CORRECT RESULTS FOR THE PATIENTS IMPACTED AND REPORTED THAT THEY DID NOT PROVIDE CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO ELEVATED COL/EPI AND COL/ADP RESULTS OBTAINED ON THE PATIENT SAMPLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7689186 ↗