UniCel DxH 800 (REF B24802)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 15099590672423), received between Feb 6, 2018 and Feb 10, 2026 — classified as 8 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (9 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 13, 2025Open, Classified

   Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

   Z-2574-2025 · Root cause: Component change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2026Output Problem

  THE CUSTOMER REPORTED THAT THEIR DXH800 HEMATOLOGY INSTRUMENT GENERATED ERRONEOUSLY LOW PLATELET (PLT) RESULTS FOR A PATIENT WITH A MALIGNANT HEMATOPATHY (MYELODYSPLASIA). THE INITIAL PLT RESULT WAS APPROXIMATELY 10 G/L AND WHEN THE PATIENT UNDER WENT TESTS IN ANOTHER LABORATORY THE RESULTS WAS ABOVE 20G/L. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. BECAUSE OF THEIR PRE-EXISTING CONDITION, THE PATIENT RECEIVED TRANSFUSIONS BASED ON THE PLT RESULT. WHEN THE PLT VALUE IS >20 G/L IT DOES NOT LEAD TO TRANSFUSION, WHEN THE RESULTS IS 10 G/L, THE PATIENT IS SYSTEMATICALLY TRANSFUSED. THE PATIENT WAS SYSTEMATICALLY TRANSFUSED BASED ON THE DXH800 RESULTS OF APPROXIMATELY 10 G/L. THE CUSTOMER STATED THAT THIS DIFFERENCE REPRESENTS A SIGNIFICANT CLINICAL DISCREPANCY. THE PATIENT RECEIVED MULTIPLE TRANSFUSIONS; HOWEVER, NO ADVERSE EFFECTS OR CLINICAL COMPLICATIONS RELATED TO THE TRANSFUSIONS WERE OBSERVED. THE PATIENT DATA PROVIDED BY THE CUSTOMER SHOWS THAT THE RESULTS WERE FLAGGED WITH 'R' FLAGS THAT PROMPT THE OPERATOR TO REVIEW THE RESULTS BEFORE RELEASIING THEM OUT OF THE LABORATORY. THE FLAGGED RESULTS WERE RELEASED WITHOUT ADDITIONAL VERIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24310432 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE BEC FIELD SERVICE MANAGER REPORTED THAT A BEC FIELD SERVICE ENGINEER (FSE) WAS INJURED WHILE TROUBLESHOOTING THE CUSTOMER¿S DXH 800 HEMATOLOGY INSTRUMENT. DURING TROUBLESHOOTING THE CUSTOMER'S DXH 800 HEMATOLOGY INSTRUMENT, THE FSE INJURED HIS RIGHT SHOULDER DUE TO LIFTING A COVER ON THE INSTRUMENT SEVERAL TIMES. THE DOOR NEEDS TO BE REMOVED EACH TIME TO SERVICE THE AREA AND NEEDED TO BE PLACED BACK ON TO ENGAGE THE SAFETY MEASURES ON THE UNIT. PER INCIDENT REPORT (B)(4), THE FIELD SERVICE MANAGER INDICATED THAT THE FSE PLACED THE RIGHT HAND ON BACK OF INSTRUMENT DOOR FROM LOWER RIGHT, WITH THE LEFT HAND ON TOP OF THE LEFT FRONT SIDE OF THE DOOR, LIFTED DOOR WITH BOTH HANDS AND FELT POPPING IN RIGHT SHOULDER. THE FSE WAS INITIALLY SEEN BY THEIR PRIMARY CARE PHYSICIAN (PCP) ON (B)(6) 2024. THE PCP DID NOT PROVIDE A DIAGNOSIS AND IMAGING WAS NOT DONE OF THE AFFECTED AREA. THE FSE WAS INSTRUCTED TO USE OVER THE COUNTER (OTC) CREAM FOR PAIN RELIEF AND TOLD TO FOLLOW UP WITH AN ORTHOPEDIC SPECIALIST AND GET X-RAYS OF THE AFFECTED AREA. THERE WERE NO WORK RESTRICTIONS REQUIRED BY THE PCP. THE FSE RECEIVED X-RAYS ON (B)(6) 2024 AND THE RESULTS OF THE IMAGING WERE CONSIDERED NORMAL. ON

  Patient problems: Pain

  MAUDE report 19934793 ↗
• MalfunctionFeb 3, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED ERRONEOUS HIGH PLATELET (PLT) RESULTS WERE GENERATED ON FOUR PATIENT SAMPLES ON THEIR DXH 800 HEMATOLOGY INSTRUMENT WHEN COMPARED TO RUNS ON OTHER INSTRUMENTS. OF THE FOUR RESULTS THAT GENERATED ERRONEOUS HIGH PLT TWO OF THE RESULTS GENERATED RBC FRAGMENT FLAGS. THE OTHER TWO RESULTS DID NOT GENERATE ANY FLAGS. ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16298883 ↗
• MalfunctionJan 25, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED ERRONEOUS HIGH PLATELETS (PLT) RESULTS WERE GENERATED ON PATIENT SAMPLES ON THEIR DXH 800 INSTRUMENT WHEN COMPARED TO RERUNS ON ANOTHER INSTRUMENT. A PRINTOUT PROVIDED BY THE CUSTOMER SHOWS THAT A SAMPLE RUN ON THE INSTRUMENT GAVE A PLT RESULT OF 94 WITH NO FLAGS AND WAS CONSIDERED ERRONEOUS. THE CUSTOMER RERAN THE SAMPLE AFTER TROUBLESHOOTING AND THE INSTRUMENT GAVE A PLT RESULT OF 65 WHICH WAS CONSIDERED CORRECT. THE ERRONEOUS RESULTS WERE IDENTIFIED BEFORE BEING RELEASED AND DID NOT LEAVE THE LABORATORY. THERE WAS NO IMPACT OR CHANGE TO PATIENT TREATMENT. THERE WAS NO REPORT OF AN ADVERSE EVENT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16243866 ↗
• MalfunctionFeb 16, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED PATIENT SAMPLES RECOVERED WITH HIGH PLATELET (PLT) RESULTS AND NO SUSPECT MESSAGING WHEN CYCLED ON THEIR UNICEL DXH800 INSTRUMENT COMPARED TO A RERUN ON AN ALTERNATE INSTRUMENT. PRINTOUTS OF THE EVENT WERE REQUESTED, BUT NOT PROVIDED. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13544410 ↗
• MalfunctionNov 30, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED RECOVERING HIGH PLATELET (PLT) VALUES FOR ONE PATIENT SAMPLE AND QC FAILURES ON THEIR DXH 800 HEMATOLOGY INSTRUMENT. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LAB BUT IDENTIFIED AND CORRECTED BEFORE THERE WAS ANY IMPACT TO THE PATIENT. THERE WAS NO ADVERSE EVENT OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. PATIENT DATA WAS NOT PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12889028 ↗
• InjuryJun 15, 2021Leak/Splash; Blocked Connection; Leak/Splash; Blocked Connection

  THE FIELD SERVICE ENGINEER (FSE) REPORTED THAT WHILE REMOVING A CLOG FROM THE DXH800 INSTRUMENT WITH A SYRINGE, BLEACH SPLASHED INTO THE EYE OF AN OPERATOR WHO WAS OBSERVING. WHILE TROUBLESHOOTING THE WHITE BLOOD CELL (WBC) BATH, THE FSE PUSHED BLEACH THROUGH THE CLOGGED LINES WITH A SYRINGE AND TUBING BECAME LOOSE AND SPLASHED BLEACH. AN OPERATOR FROM THE LABORATORY WAS OBSERVING AND BLEACH SPLASHED INTO THEIR EYES. THE OPERATOR THEN RINSED THEIR EYES AT THE WASH STATION AND AFTER THAT WAS TAKEN TO THE EMERGENCY ROOM. THE OPERATOR WAS PRESCRIBED AN EYE OINTMENT. THE OPERATOR WAS OUT FROM WORK FOR TWO DAYS BUT HAS SINCE RETURNED AT FULL CAPACITY AND FULLY RECOVERED FROM THE INCIDENT. THE OPERATOR WAS WEARING ONLY A LABORATORY COAT FOR PPE AND WAS NOT WEARING FACE PROTECTION AT THE TIME OF THE INCIDENT.

  Patient problems: Eye Injury

  MAUDE report 12000503 ↗
• MalfunctionApr 4, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THEIR DXH 800 HEMATOLOGY INSTRUMENT GENERATED QUESTIONABLE RESULTS ON ONE PATIENT SAMPLE WHICH WAS RERUN ON A SECOND INSTRUMENT AND GAVE A RESULT WITHIN THE EXPECTED RANGE. THE QUESTIONABLE INITIAL RESULTED IN A HIGHER PLATELET (PLT) COUNT AND LOWER RED BLOOD CELL (RBC) AND HEMOGLOBIN (HGB) THAN EXPECTED. A MANUAL SMEAR AS PERFORMED AND DID NOT COINCIDE WITH THE PLATELET RESULT GENERATED BY THE DXH 800. THE DXH 800 REPORTED A 996 PLT COUNT, HGB 106 COUNT, AND RBC OF 3.25 WITH NO INSTRUMENT GENERATED ERROR MESSAGES OR FLAGS. THE SECOND ANALYZER REPORTED PLT OF 135, HGB OF 132 AND RBC OF 4.5, THESE RESULTS WERE CONSISTENT WITH PATIENT HISTORY AND CONSIDERED CORRECT. THE CUSTOMER REVIEWED AND CONFIRMED THAT ALL OTHER PATIENT RESULTS GENERATED IN THE IMMEDIATE TIME FRAME WERE CONSIDERED CORRECT. THERE WAS NO ADVERSE EFFECT TO THE PATIENT. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11612073 ↗
• InjuryJul 21, 2020Leak/Splash; Leak/Splash

  THE BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) REPORTED THAT WHILE SERVICING THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM AT THE CUSTOMER SITE THE WASTE DRAIN TUBING CAME OFF ACCIDENTALLY, SPLASHING HIM ON THE RIGHT SIDE OF THE FACE AND IN THE RIGHT EYE. THIS EVENT DID NOT LEAD TO A PERMANENT PHYSICAL DAMAGE OR IMPAIRMENT, WITH NO LOSS OR REDUCTION IN EYESIGHT. THERE WAS NO SERIOUS INJURY ASSOCIATED TO THIS EVENT. THE FSE CONSULTED AN OPHTHALMOLOGIST, WHO DID NOT IDENTIFY ANY INJURY OR OCULAR DAMAGE IN THE RIGHT EYE, WHICH WAS DIRECTLY SPLASHED WITH THE BIOHAZARDOUS WASTE. PER ADDITIONAL INFORMATION PROVIDED ON 07-JUL-20, THE FSE WAS DOING WELL, AND THERE WAS NO REPORTED ADVERSE REACTION, SINCE THE DATE OF OCCURRENCE. THE FSE RECEIVED POST-EXPOSURE PROPHYLAXIS TREATMENT FOR THE REPORTED INCIDENT AND WAS PRESCRIBED MEDICATION FOR THE POTENTIAL EXPOSURE. PER FSE, THE DOCTOR PRESCRIBED A COURSE OF (B)(6).

  Patient problems: Eye Injury

  MAUDE report 10305762 ↗
• MalfunctionApr 20, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED RECOVERING FLAGGED AND UNFLAGGED HIGH PLATELET (PLT) RESULTS ON BACKGROUNDS AND PATIENT SAMPLES RUN ON THEIR UNICEL DXH 800 INSTRUMENT. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9979817 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS AT A CUSTOMER SITE PERFORMING A SCHEDULED PREVENTATIVE MAINTENANCE (PM) ON THEIR UNICEL DXH800 INSTRUMENT. DURING THE COURSE OF PERFORMING THE PM, THE FSE EXPERIENCED ELBOW PAIN TO THE POINT WHERE HE COULD NOT CONTINUE TO WORK. THE FSE HAD BEEN EXPERIENCING ELBOW SORENESS FOR A COUPLE OF WEEKS BEFORE PERFORMING THE PM. THE FSE WAS ATTEMPTING TO REMOVE RETAINING RING ON THE DISTRIBUTION VALVE ASSEMBLY INSIDE THE CUSTOMER¿S DXH800 INSTRUMENT DURING PM BY TWISTING IT OFF BY HAND. THIS TWISTING ACTION INFLAMED THE ALREADY SORE ELBOW AREA. THE FSE HAD BEEN FOLLOWING HIS DOCTOR¿S PREVIOUS RECOMMENDATION OF ICING THE ELBOW.

  Patient problems: Injury

  MAUDE report 9709094 ↗
• MalfunctionOct 25, 2019Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT MULTIPLE ERRONEOUS HIGH PLATELET (PLT) RESULTS WERE GENERATED BY THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS INSTRUMENT. THE CUSTOMER STATED THAT THERE WERE BOTH FLAGGED AN UNFLAGGED RESULTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, WITH THE CURRENT INFORMATION AVAILABLE IT IS NOT KNOWN HOW MANY PATIENTS WERE AFFECTED BY THIS EVENT. THE CUSTOMER REPORTED THAT SOME RESULTS HAD BEEN RELEASED BY THE TIME SHE BECAME AWARE OF THIS ISSUE. SOME OF THE PATIENTS HAD THEIR RESULTS CORRECTED. THERE WAS NO REPORT OF IMPACT TO PATIENT OR CHANGE IN PATIENT TREATMENT CONNECTED TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9241434 ↗
• InjuryJul 11, 2019Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM HAD GENERATED WBC CARRYOVER AND VARIABLE LYMPH MESSAGES WHILE RUNNING S SAMPLE. THIS PROMPTED A MANUAL SLIDE ASSESSMENT FOR THE PATIENT AND AS A RESULT OF THE SLIDE, THE PATIENT WAS THOUGHT TO HAVE RELAPSED AND A BONE MARROW DRAWING WAS DONE. THE SAMPLE WAS FOR A (B)(6) YEAR OLD FEMALE PATIENT WITH ACUTE MYELOID LEUKEMIA (AML). THE SLIDE REVIEW PROMPTED THE BONE MARROW PROCEDURE. IT WAS CONFIRMED THAT THE PATIENT HAD NOT RELAPSED AS INITIALLY SUSPECTED. THE PATIENT RECOVERED FROM THE PROCEDURE WITHOUT COMPLICATION.

  Patient problems: Misdiagnosis; Test Result

  MAUDE report 8782923 ↗
• MalfunctionJun 28, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM GENERATED ERRONEOUS HIGH PLATELET (PL:T) COUNTS, WITHOUT ANY FLAGS, FOR A SINGLE PATIENT WITH MYELODYSPLASTIC SYNDROMES (MDS). THE CUSTOMER REPORTED THAT THE INSTRUMENT DID NOT FLAG THE PLATELET RESULTS THAT HAD BEEN FLAGGED LOW BY THE REFERENCE INTERVAL. A MANUAL COUNT WAS DONE BY THE CUSTOMER AND INDICATED THAT THE PLATELET COUNT WAS EVEN LOWER. THE CUSTOMER INDICATED THAT COUNTS WERE CONSIDERED ERRONEOUSLY HIGH, IN COMPARISON TO THE COUNT EXPECTED FOR THE CLINICAL CONDITION OF THIS PATIENT. THE SENIOR APPLICATIONS SCIENTIST (SAS) FOR THIS CUSTOMER INDICATED THAT THE DOCTOR AT THIS INSTITUTION WAS AWARE OF THE CONDITION OF THE PATIENT (MYELODYSPLASTIC SYNDROMES (MDS)). PATIENT DATA PROVIDED SHOWS THAT THE INSTRUMENT FLAGGED FOR REFERENCE (USER DEFINED) LIMITS (L) FOR PLATELETS, AND TRIGGERED A SUSPECT MESSAGE FOR THE PRESENCE OF ABNORMAL RET IN THE SAMPLE, INDICATING THE OPERATOR THAT THE RESULTS HAD TO BE REVIEWED ACCORDING TO THEIR LABORATORY¿S PROTOCOL. THE CUSTOMER STATED THAT THE SUSPECT RESULTS WERE NOT REPORTED OUT OF THE LAB.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8746451 ↗
• MalfunctionJun 21, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED GETTING ERRONEOUSLY ELEVATED PLATELET (PLT) ON PATIENT SAMPLES ON THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8725071 ↗
• InjuryFeb 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THEIR DXH 800 HEMATOLOGY INSTRUMENT GENERATED ERRATIC ERRONEOUS PLATELET (PLT) COUNTS FOR A PATIENT UNDERGOING CHEMOTHERAPY. A DELAY IN PATIENT TREATMENT OCCURRED AS A RESULT OF THIS EVENT. THE CUSTOMER INDICATED THAT THERE WERE NO ADVERSE EVENTS ASSOCIATED WITH THIS EVENT AND THE IMPACT TO TREATMENT WAS THE DELAY OF A TRANSFUSION. THE PHYSICIAN KNEW THE PATIENT AND THE RESULTS WERE INCONSISTENT WITH THE PATIENT'S CLINICAL HISTORY. THE RESULTS WERE THEN SUBMITTED FOR MANUAL COUNT AND VERIFIED ON A NON-BECKMAN COULTER INSTRUMENT. PRINTOUTS PROVIDED AS EVIDENTIARY SUPPORT FOR THIS EVENT, INDICATE THAT THE INSTRUMENT FLAGGED THE SAMPLE RESULTS, TRIGGERING SUSPECT MESSAGES (GIANT PLATELETS), SYSTEM MESSAGES (PLATELETS AGGREGATES, RBC-PLT OVERLAP), AND R-FLAGS FOR THE SPECIMENS. THE FLAGS NOTIFY THE OPERATOR TO REVIEW THE RESULTS ACCORDING TO THEIR LABORATORY'S POLICY FOR REVIEWING THE PATIENT SAMPLE RESULTS.

  Patient problems: Test Result

  MAUDE report 8300417 ↗
• InjuryFeb 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THEIR DXH 800 HEMATOLOGY INSTRUMENT GENERATED ERRATIC ERRONEOUS PLATELET (PLT) COUNTS FOR A PATIENT UNDERGOING CHEMOTHERAPY. A DELAY IN PATIENT TREATMENT OCCURRED AS A RESULT OF THIS EVENT. THE CUSTOMER INDICATED THAT THERE WERE NO ADVERSE EVENTS ASSOCIATED WITH THIS EVENT AND THE IMPACT TO TREATMENT WAS THE DELAY OF A TRANSFUSION. THE PHYSICIAN KNEW THE PATIENT AND THE RESULTS WERE INCONSISTENT WITH THE PATIENT'S CLINICAL HISTORY. THE RESULTS WERE THEN SUBMITTED FOR MANUAL COUNT AND VERIFIED ON A NON-BECKMAN COULTER INSTRUMENT. PRINTOUTS PROVIDED AS EVIDENTIARY SUPPORT FOR THIS EVENT, INDICATE THAT THE INSTRUMENT FLAGGED THE SAMPLE RESULTS, TRIGGERING SUSPECT MESSAGES (GIANT PLATELETS), SYSTEM MESSAGES (PLATELETS AGGREGATES, RBC-PLT OVERLAP), AND R-FLAGS FOR THE SPECIMENS. THE FLAGS NOTIFY THE OPERATOR TO REVIEW THE RESULTS ACCORDING TO THEIR LABORATORY¿S POLICY FOR REVIEWING THE PATIENT SAMPLE RESULTS.

  Patient problems: Test Result

  MAUDE report 8300416 ↗
• MalfunctionJul 30, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM GENERATED FALSE HIGH PLATELET (PLT) RESULTS. THERE WAS NO REPORT OF CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION WITH THE REPORTED EVENT. PATIENT DATA WAS NOT PROVIDED BY THE CUSTOMER FOR THIS EVENT.

  Patient problems: Test Result

  MAUDE report 7730956 ↗
• MalfunctionJul 27, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM GENERATED ERRONEOUS HIGH PLATELET (PLT) RESULTS ON ONE PATIENT SAMPLE WITH ITP (IDIOPATHIC THROMBOCYTOPENIC PURPURA). THE CUSTOMER REPORTED THAT ONE SAMPLE FROM A PATIENT WITH ITP RETURNED A VALUE OF 129 FOR PLT. THE RESULT DID NOT MATCH THE PATIENTS¿ CLINICAL HISTORY SO THE SAMPLE WAS RERUN ON ANOTHER INSTRUMENT WHICH GAVE A VALUE OF 8 FOR PLT. THE LOWER VALUE WAS CONSIDERED CORRECT. ALTHOUGH ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY, THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT.

  Patient problems: Test Result

  MAUDE report 7728946 ↗
• MalfunctionJul 27, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM GENERATED ERRONEOUS HIGH PLATELET (PLT) RESULTS ON 75 PATIENT SAMPLES COMPARED TO ANOTHER DXH800 INSTRUMENT. THE CUSTOMER PROVIDED INSTRUMENT PRINTOUTS FOR SIX PATIENT SAMPLES. REVIEW OF THE PRINTOUTS SHOWS THAT SIX PATIENT SAMPLES GAVE ERRONEOUS HIGH PLT RESULTS COMPARED TO RERUNS IN ANOTHER DXH800 INSTRUMENT WHICH WERE CONSIDERED CORRECT. TWO OF THE SIX PRINTOUTS PROVIDED SHOWED INSTRUMENT FLAGS WHICH ALERTED THE OPERATOR TO REVIEW THE RESULTS. THE OTHER FOUR PATIENTS DID NOT SHOW ANY FLAGS. RAW DATA OR PRINTOUTS WERE NOT PROVIDED FOR THE OTHER ALLEGED ERRONEOUS RESULTS. ON (B)(6) 2018, THE CUSTOMER PROVIDED MORE DETAILS REGARDING THE REPORTED HIGH PLT COUNTS. THERE WAS A TOTAL OF 75 PATIENTS THAT GENERATED FALSE HIGH PLT RESULTS. THE CUSTOMER REPORTED THAT THEIR CONSULTANT HEMATOLOGIST REPORTED TO THEM THAT TWO PATIENTS WITH ITP (IDIOPATHIC THROMBOCYTOPENIC PURPURA) HAD ABNORMALLY HIGH PLT RESULTS. A PATIENT WHOSE PLT VALUE IS NORMALLY LESS THAN 10 GAVE A PLT COUNT OF 149 AND ANOTHER PATIENT WHOSE PLT VALUE IS NORMALLY LESS THAN 15 GAVE A PLT COUNT OF 161. REVIEW OF THE PRINTOUTS SHOWED THAT THE ERRON

  Patient problems: Test Result

  MAUDE report 7728520 ↗
• MalfunctionJul 27, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM GENERATED HIGH PLATELET (PLT) COUNTS ON PATIENT SAMPLES AND BACKGROUNDS. THE CUSTOMER REPORTED THAT THE PLATELET COUNTS WERE RUNNING TWICE AS HIGH ON SAMPLES AND BACKGROUNDS. PLATELET BACKGROUNDS WERE FAILING AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF ERRONEOUS RESULTS REPORTED OUT OF THE LAB FROM THE PROVIDED INFORMATION. THERE WAS NO REPORT OF CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION WITH THE REPORTED EVENT.

  Patient problems: Test Result

  MAUDE report 7726813 ↗
• MalfunctionJul 20, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED THAT THEIR UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM WAS GENERATING HIGH PLATELET (PLT) RESULTS ON PATIENT SAMPLES WHICH WERE SIGNIFICANTLY LOWER WHEN REPEATED ON THE OTHER UNIT IN THE LABORATORY. CUSTOMER STATED THAT ERRONEOUS PATIENT RESULTS (22 TOTAL) THAT WERE REPORTED OUT WERE CORRECTED AND THAT THEY DO NOT BELIEVE THERE WAS ANY CHANGE TO PATIENT TREATMENT. THE PATIENT DATA THAT WAS PROVIDED BY THE CUSTOMER ARE FROM THE LIS FILES. CUSTOMER DOES NOT PRINT PATIENT RESULTS BUT SPOT-CHECKED A FEW PATIENT RESULTS ON THE INSTRUMENT AND FOUND THE RESULTS ERRONEOUS RESULTS WERE NOT FLAGGED BY THE INSTRUMENT.

  Patient problems: Test Result

  MAUDE report 7708047 ↗
• MalfunctionJul 13, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSE HIGH PLATELET (PLT) RESULTS WERE GENERATED ON A UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THERE WERE NO FLAGS OR SYSTEM MESSAGES REPORTED BY THE CUSTOMER. THE CUSTOMER RERAN THE SAMPLE ON A COMPETITIVE ANALYZER, WHICH GENERATED LOWER RESULTS. THE COMPETITIVE ANALYZER RESULTS CORRELATED WITH THE PLT COUNT FROM A MANUAL SLIDE REVIEW. THERE WAS NO EFFECT OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7688466 ↗
• MalfunctionMar 30, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER CLAIMED THAT THEIR DXH800 HEMATOLOGY INSTRUMENT WAS FAILING PLATELET (PLT) BACKGROUNDS. THE CUSTOMER ALSO REPORTED THAT THEY HAD 7 PATIENT SAMPLES THAT GAVE ERRONEOUS HIGH PLT RESULTS. ON (B)(6) 2018, VIA TELEPHONE THE LAB TECHNICIAN HAD CONFIRMED THAT THE INSTRUMENT HAD GENERATED FLAGS AND THEY HAD REVIEWED THE RESULTS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER WAS CONTACTED AGAIN ON (B)(6) 2018 BECAUSE THE LAB MANAGER AT THE CUSTOMER SITE REQUESTED MORE FEEDBACK REGARDING THE INVESTIGATION. IN THE COURSE OF THAT CONVERSATION THE LAB MANAGER PROVIDED INFORMATION THAT CONFLICTED WITH THE LAB TECHNICIAN FEEDBACK ON 03/09/2018. THE LAB MANAGER CLAIMED THAT THE FLAGS THAT WERE GENERATED WERE BASED ON THE SAMPLE AVERAGE (XB) FOR PLT AND NOT ON SPECIFIC SAMPLES GENERATED BY THE INSTRUMENT. SHE CONFIRMED THAT THE SAMPLE RESULTS DID NOT GENERATE R FLAGS AND THAT SOME RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE LAB MANAGER CONFIRMED THAT THE PRINTOUTS OR RAW DATA WERE NOT AVAILABLE FOR THE AFFECTED PATIENTS. THERE WAS NO CHANGE TO PATIENT TREATMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7387027 ↗
• MalfunctionMar 9, 2018Improper Device Output; Improper Device Output

  THE CUSTOMER REPORTED RECOVERING ERRONEOUS INCREASED PLT RESULTS ON A SINGLE PATIENT SAMPLE WITH KNOWN LOW PLTS ON THE DXH 800 INSTRUMENT. ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY, HOWEVER THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT. THERE WAS NO IMPACT TO CONTROLS.

  Patient problems: Test Result

  MAUDE report 7329530 ↗