BD FACSCalibur 342975Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00382903429752), received between Apr 26, 2019 and May 17, 2024 — classified as 62 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (35 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 25 most recent of 62 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD FACSCALIBUR¿ FLOW CYTOMETER: 4 COLOR ERRONEOUS RESULTS OCCURRED AND REPORTED TO THE DOCTOR. NO PATIENT TREATMENT DELAY AND NO PATIENT INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT THERE WAS SAMPLE FROM ONE PATIENT WHERE CD4+ WAS NOT DETECTED EVEN THOUGH IT WAS CONFIRMED BY OTHER LABORATORY THAT THESE ARE PRESENT. AT THE MOMENT IT IS NOT KNOWN WHERE THE FAULT LIES (SAMPLE PREPARATION, ANTIBODIES (BOUGHT FROM BD) OR ON THE INSTRUMENT ITSELF, THUS THE CASE IS BEING OPEN FOR INVESTIGATION PURPOSES. THE CD4 WAS NOT DETECTED IN THE BLOOD SAMPLE FROM ONE PATIENT (BUT WAS FOUND IN THE DIFFERENT LABORATORY IN FRANKFURT). THE CONTROLS WERE DETECTED SO CUSTOMER DOES NOT UNDERSTAND WHY IT HAPPENED AND TRIES TO GET TO THE BOTTOM OF THIS. THE DOCTOR WAS INFORMED - NO TREATMENT WAS AFFECTED BY THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19346387 ↗
• MalfunctionJul 24, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD FACSCALIBUR¿ FLOW CYTOMETER THAT THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CASE RELATED TO A EVENT RATE ISSUE; VALUES WERE NOT NORMAL AND WAS DUE TO A MISCONFIGURATION NO RESULTS INVOLVED, WERE ACTUALLY VALUES WITH BOTH SAMPLES, BUT WERE NOT RELEASED. COULD YOU CLARIFY WHAT THE "UNEXPECTED RESULTS" WOULD BE? VALUES WERE NOT NORMAL AND WAS DUE TO A MISCONFIGURATION WERE THE UNEXPECTED RESULTS WITH CONTROL SAMPLES OR WITH PATIENT SAMPLES? NO. RESULTS WERE ACTUALLY VALUES WITH BOTH SAMPLES, BUT WERE NOT RELEASED, SO THE PATIENT WAS NOT TREATED BASED ON THE RESULT AND WAS NOT SUBJECTED TO HARM. IF PATIENT SAMPLES, WERE INCORRECT RESULTS OBTAINED OR USED? NO. WAS THE PATIENT TREATED BASED ON THE OUTCOME? NO. WAS THERE ANY HARM TO THE PATIENT? NO. EQUIPMENT DID NOT ENABLE FL4 AT POWER UP, BEING NECESSARY TO ENABLE IT MANUALLY FOR CALIBRATION. HOWEVER, AFTER ACQUIRING THE SAMPLES THE RESULTS SHOWED UNEXPECTED RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379804 ↗
• MalfunctionMay 26, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD FACSCALIBUR¿ FLOW CYTOMETER THAT THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT TODAY WHEN TURNING ON THE EQUIPMENT, THE CALIBRATION GAVE SOME ERRORS IN BOTH TUBE A AND TUBE B AND WHEN REPEATING THE PROCEDURE THEY WERE SUCCESSFUL, BUT THEY REREAD SAMPLES TAKEN THE DAY BEFORE AND THE RESULT WAS DIFFERENT. ACCORDING TO THEM, TO CARRY OUT A MORE RELIABLE COMPARISON, THEY REPEATED THE ACQUISITION WITH THE SAME SAMPLE SEVERAL TIMES AND THE RESULTS WERE DIFFERENT, OBTAINING A DIFFERENCE OF UP TO 50% IN THE COUNT OF THE CELLS IN QUESTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009968 ↗
• MalfunctionMar 31, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD FACSCALIBUR¿ FLOW CYTOMETER THAT THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FACSCALIBUR-INACCURATE RESULTS. CLINICAL USE, USED PATIENT SPECIMENS BUT NOT APPLIED TO PATIENT TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16659786 ↗
• MalfunctionMar 14, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD FACSCALIBUR¿ FLOW CYTOMETER THAT THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FACSCALIBUR - UNEXPECTED RESULT CLINICAL, NOT USED FOR PATIENT DIAGNOSIS, NO IMPACT ON PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538395 ↗
• MalfunctionMar 9, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD FACSCALIBUR¿ FLOW CYTOMETER ACQUIRED ERRONEOUS RESULTS ON PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1 ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES 2 WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3): NO 3 IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4): NO 4 WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES OR UNKNOWN, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED): NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16513933 ↗
• MalfunctionJan 31, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD FACSCALIBUR¿ FLOW CYTOMETER THAT THERE WAS ERRONEOUS REULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HIGH CELL ABSOLUTE COUNT IS REPORTED BY THE FSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16273772 ↗
• MalfunctionJan 20, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD FACSCALIBUR¿ FLOW CYTOMETER THAT THERE WERE ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FACSCALIBUR - ABNORMAL GRAPHICS, CLINICAL USE, RESULTS NOT USED FOR PATIENT DIAGNOSIS, OUT OF WARRANTY EQUIPMENT, QUOTE REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16215381 ↗
• MalfunctionJan 17, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD FACSCALIBUR¿ FLOW CYTOMETER: 4 COLOR SAMPLE RESULTS IS INCORRECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SAMPLE RESULT NOT CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16190683 ↗
• MalfunctionNov 8, 2022Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED THAT WHILE USING THE BD FACSCALIBUR¿ FLOW CYTOMETER THAT THERE WAS ELECTRICAL SHOCK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT PRESENTS DISCHARGES ON THE SURFACE OF THE INSTRUMENT.

  Patient problems: Electric Shock

  MAUDE report 15754793 ↗
• MalfunctionOct 6, 2022Non Reproducible Results; Non Reproducible Results

  IT WAS REPORTED THAT WHILE USING THE BD FACSCALIBUR¿ FLOW CYTOMETER THAT THE LYMPHS COUNTS IS BELOW 2000. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE USER REPORTS THAT THE LYMPHS COUNTS IS BELOW 2000.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15554986 ↗
• MalfunctionSep 19, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD FACSCALIBUR¿ FLOW CYTOMETER: 4 COLOR INSTRUMENT GIVING WRONG RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WERE THE SAMPLES ANALYZED ON THE INSTRUMENT PATIENT SAMPLES? YES. IF THEY WERE PATIENT SAMPLES, WERE INCORRECT RESULTS OBTAINED OR USED? YES. ANY TREATMENT PROVIDE TO THE PATIENT BASED ON THE RESULT? NO. THE USER NOTICED THE ANOMALY BEFORE REPORTING, HENCE DIDN'T REPORT. WAS THERE ANY HARM TO THE PATIENT? NO, THE PATIENTS WERE ATTENDED TO BASED ON PREVIOUS RECORD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15451361 ↗
• MalfunctionSep 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER THAT BD FACSCALIBUR¿ FLOW CYTOMETER HAD WASTE LEAKAGE WITHOUT BLEACH NOT CONTAINED (OUTSIDE INSTRUMENT). THERE WAS ONE OCCURRENCE IN THIS EVENT WITH NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: FACSCALIBUR - UNABLE TO FLUSH SYRINGE OUTER TUBE CLINICAL USE." WAS THE LEAK LIQUID OR AIR? (IF LIQUID/BOTH, GO TO QUESTION #2. IF AIR, NO FURTHER QUESTIONS REQUIRED.): LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? ( IF NOT CONTAINED, GO TO QUESTION #3. IF CONTAINED, NO FURTHER QUESTIONS REQUIRED.): NOT CONTAINED. WAS THERE SPRAY OF LIQUID? (IF YES, DESCRIBE THE LIQUID THAT SPRAYED THEN GO TO QUESTION #7. IF NO, TYPE "NO" IN THE TEXT BOX THEN GO TO QUESTION #4): NO. 4 WHAT WAS THE FLUID THAT LEAKED? (IF NON BIOHAZARD, NO FURTHER QUESTIONS REQUIRED. IF BIOHAZARD/UNKNOWN, GO TO QUESTION #5): THE LIQUID WASTE 5 DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? (IF BEFORE WASTE LINE OR UNKNOWN, GO TO QUESTION #7. IF AFTER WASTE LINE, GO TO QUESTION #6): BEFORE WASTE LINE 7 WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? (IF YES, GO TO QUESTION #8. IF NO, NO FURTHER QUESTIONS REQUIRED.) PHYSICAL CONTACT INCLUDE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15427905 ↗
• MalfunctionAug 11, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT ON THE BD FACSCALIBUR¿ FLOW CYTOMETER IT WAS NOT POSSIBLE TO IDENTIFY WHY THE SOFTWARE DID NOT CORRECTLY PROCESS THE SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? PATIENT. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? YES. WAS THE PATIENT TREATED BASED ON ERRONEOUS RESULTS? NO. SPECIFY IF ANY TESTING DONE WAS IVD OR RUO. IVD. WERE RESULTS REPORTED TO A PATIENT OR CLINICIAN AND ACTED ON? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15210628 ↗
• MalfunctionJun 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BD FACSCALIBUR¿ FLOW CYTOMETER WAS LEAKING OUTSIDE OF THE INSTRUMENT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. INSTRUMENT LEAKING. LEAK CHECKLIST: WAS THE LEAK LIQUID OR AIR? LIQUID , WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED,WAS THERE SPRAY OF LIQUID? NO, WHAT WAS THE FLUID THAT LEAKED? UNKNOWN , DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? AFTER WASTE LINE, WAS THE WASTE MIXED WITH DECONTAMINATE/BLEACH? NO, WAS THE CUSTOMER/ BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14832632 ↗
• MalfunctionJun 3, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD FACSCALIBUR¿ FLOW CYTOMETER ACQUIRED ERRONEOUS RESULTS ON PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HIGH ABSOLUTE COUNTS: ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? (IF YES, GO TO QUESTION #2, IF NO, NO FURTHER QUESTIONS REQUIRED.) . WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3). IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4). WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED). PROVIDE DETAILS - HOW AND TO WHAT EXTENT? (GO TO QUESTION #6). WHAT IS THE CURRENT MEDICAL STATUS? (NO FURTHER QUESTIONS REQUIRED.). YES THEY WERE ERRONEOUS RESULTS ON PATIENT SAMPLES, HOWEVER UPON OBSERVING THIS ANOMALY WE IMMEDIATELY STOPPED USING THE EQUIPMENT. THERE WAS NO DELAY OF TREATMENT - WE HAVE OTHER BACKUP ANALYSERS, HENCE OUR RESULTS TAT WAS NOT AFFECTED. NO SAMPLES WERE REDRAWN, THE FAILED SAMPLES WERE SUCCESSFULLY RE-RUN ON THE BACKUP ANALYSER. NO PHYSICALLY HARM/INJURY TO THE PATIENT. N/A."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14592033 ↗
• MalfunctionMay 13, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD FACSCALIBUR¿ FLOW CYTOMETER ACQUIRED ERRONEOUS RESULTS ON PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AS PER THE MENTION ON THE ENTRY DESCRIPTION " SOME PATIENTS' RESULTS FOR CD45 ARE NOT CONSISTENT WITH THE COUNT PROVIDED BY THE HEMATOLOGICAL CONTACTOR." SO COULD YOU PLEASE PROVIDE THE PATIENT SAFETY QUESTION ? ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? IF YES, GO TO QUESTION, IF NO, NO FURTHER QUESTIONS REQUIRED. YES. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? GO TO QUESTION, NO. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? GO TO QUESTION, NO. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? IF YES, GO TO QUESTION, IF NO, NO FURTHER QUESTIONS REQUIRED. NO. PROVIDE DETAILS HOW AND TO WHAT EXTENT? GO TO QUESTION, WHAT IS THE CURRENT MEDICAL STATUS? NO FURTHER QUESTIONS REQUIRED. NO. HOW MANY WRONG RESULTS WERE OBTAINED? 3 PATIENTS REPORTED. WHAT CONFIRMATORY TEST WAS PERFORMED TO DETERMINE THE FALSE POSITIVE/NEGATIVE RESULT? THE RESULT OF TWO HEMATOLOGICAL COUNTERS WAS USED, WHICH FOUND A DIFFERENCE IN THE LEUKOCYTE COUNT. HAVE ANY INC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14399655 ↗
• MalfunctionApr 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BD FACSCALIBUR FLOW CYTOMETER: 4 COLOR LEAKED BIOHAZARD FLUID OUTSIDE THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "LIQUID IS LEAKING FROM THE HOLE ON THE BACK SIDE UNDER THE SHEATH TANK." "THE USER DECLARES THAT THE TANK ITSELF IS LEAKING." WAS THE LEAK FLUID OR AIR? FLUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14054008 ↗
• MalfunctionApr 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE USING BD FACSCALIBUR¿ FLOW CYTOMETER: 4 COLOR LEAKAGE OF BIOHAZARD COMING FROM THE INSTRUMENT WAS DETECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER WAS ASKED TO FLUSH THE TUBING WITH A SYRINGE. IT WAS AGREED WITH THE CUSTOMER THAT IF THE PROBLEM RECURRED, THEY WOULD GET IN TOUCH. THE CUSTOMER HASN'T CONTACTED US, SO I ASSUME THE DEVICE WAS WORKING PROPERLY. DROPS FROM THE NEEDLE WHILE ON STANDBY, WITH YOUR ARM ON YOUR LEFT. THE USER HEARS THE DCM PUMP. HE CORRECTED THE HOSE ON THE PUMP. THE CUSTOMER WAS ASKED TO FLUSH THE TUBING WITH A SYRINGE. DROPS FROM THE NEEDLE WHILE ON STANDBY, WITH YOUR ARM ON YOUR LEFT. WAS THE LEAK FLUID OR AIR? IF AIR, NO FURTHER QUESTIONS REQUIRED. FLUID WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? DOES NOT INCLUDE OUTSIDE ENTIRE INSTRUMENT, AND CONTAINED WITHIN DESIGNED INNER ENCLOSURE? NO. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. WAS THERE SPRAY OF FLUID UNDER PRESSURE ? NO. WHAT WAS THE FLUID THAT LEAKED? BIO HAZARD OR NON BIO HAZARD? BIO HAZARD. WHAT IS THE SOURCE OF LEAK WASTE LINE OR NON-WASTE LINE? LEAK IS BEFORE OR AFTER WASTE LINE? WASTE LINE. WAS THE CUSTOMER EXPOSED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14047707 ↗
• MalfunctionApr 1, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE BD FACSCALIBUR¿ FLOW CYTOMETER: 4 COLOR PRODUCED ERRONEOUS IVD RESULTS WHILE MEASURING LYMPHOCYTES. THERE WAS NO ADVERSE PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "CALIBRATION PASSED. WHEN MEASURING LYMPHOCYTES, EVENTS ARE SHIFTED ONTO THE AXIS ONLY AT FSC AND SSC." "THERE WERE AIR BUBBLES IN THE FILTER. THE CUSTOMER WAS ASKED TO BLEED THE FILTER AND CLEAN IT WITH FACSCLEAN." ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST? - YES. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? - YES. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? - NO. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? - NO. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? - NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13984247 ↗
• MalfunctionMar 18, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE TESTING PATIENT SAMPLES ON BD FACSCALIBUR¿ FLOW CYTOMETER ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: 342975-FACSCALIBUR CYTOMETER 4 COLOR BASIC IVD-ERRONEOUS RESULT. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? YES. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO. PROVIDE DETAILS - HOW AND TO WHAT EXTENT? NO. WHAT IS THE CURRENT MEDICAL STATUS? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13810201 ↗
• MalfunctionMar 3, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE SUPPORT ARM IS TO THE SIDE OF A BD FACSCALIBUR¿ FLOW CYTOMETER WASTE LEAKS OUTSIDE OF THE INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTS THAT THE SIP BACKDRIPS WHEN THE TUBE SUPPORT ARM IS TO THE SIDE. CLEANING THE INSTRUMENT DOES NOT RESOLVE THE ISSUE. WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THERE SPRAY OF LIQUID? NO. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? BEFORE WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATE/BLEACH? WAS THE CUSTOMER/ BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13663604 ↗
• MalfunctionFeb 23, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE TESTING PATIENT SAMPLES WITH A BD FACSCALIBUR¿ FLOW CYTOMETER ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO REPORT OF CONFIRMATORY TESTING, AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CLAIMS THAT BY REPEATING SOME SAMPLES FROM YESTERDAY, THE RESULTS ARE REPRODUCIBLE, JUST WITHOUT SHOWING THE GATE DESIGN. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? (IF YES, GO TO QUESTION #2, IF NO, NO FURTHER QUESTIONS REQUIRED.) YES. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3) NO. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4) NO. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED) NO. PROVIDE DETAILS - HOW AND TO WHAT EXTENT? (GO TO QUESTION #6) NO. WHAT IS THE CURRENT MEDICAL STATUS? (NO FURTHER QUESTIONS REQUIRED.) NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13587166 ↗
• MalfunctionFeb 1, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE TESTING PATIENT SAMPLES WITH BD FACSCALIBUR¿ FLOW CYTOMETER ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: AFTER REMEDIATION, CUSTOMERS REPORT UNEXPECTED RESULTS, WHICH MAY BE RELATED TO TRUCOUNT TUBES PERFORMING POORLY. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? YES, THE PROBLEM GENERATED ERRONEOUS RESULTS. INCORRECT RESULTS WERE NOT RELEASED. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO. THERE WAS NO CHANGE IN THE TREATMENT OF PATIENTS. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO PROVIDE DETAILS - HOW AND TO WHAT EXTENT? NA WHAT IS THE CURRENT MEDICAL STATUS? PATIENTS CONTINUED TO FOLLOW THE STANDARD TREATMENT PROVIDED BY THE SUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13418303 ↗
• MalfunctionJan 21, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD FACSCALIBUR¿ FLOW CYTOMETER ACQUIRED ERRONEOUS RESULTS ON PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I EXPLAINED THAT THE BEADS MAY HAVE DEGRADED OR LOST FLUORESCENCE AFTER EXPIRATION AND THIS AFFECTS THE CELL COUNT, BEING RECOMMENDED TO DISCARD THE EXPIRED TUBES AND USE NEW TUBES. DEGRADATION OF THE BEADS AND/OR LOSS OF THEIR FLUORESCENCE CAN MAKE CALIBUR NOT REACH THE COUNT OF 500 BEADS IN EACH SAMPLE, LEADING IT TO ACQUIRE MORE THAN 20 THOUSAND EVENTS IN THE EXAM IN AN ATTEMPT TO REACH AT LEAST 500 BEADS. THE LOW COUNT OF BEADS CAUSES THE CALCULATION OF THE CONCENTRATION OF CELLS IN THE BLOOD TO INCREASE THE FINAL RESULT, EXPLAINING WHY THE RESULTS OF THE ANALYZED PATIENTS DO NOT MATCH THE HISTORY IN THE SYSTEM. CALIBUR ACQUIRED MORE THAN 20,000 EVENTS FOR VARIOUS ROUTINE SAMPLES AND THE RESULTS WERE NOT CONSISTENT WITH THE PATIENTS' HISTORIES.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13321108 ↗