m2000 09K14-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00884999031753), received between Feb 13, 2017 and Mar 14, 2025 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (11 reports).

7 other recalls cover devices cleared under the same FDA submission (K092705); they may or may not involve this specific model.

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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2025Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  WHILE CLEANING THE WASTE CHUTE OF THE M2000SP, TWO LABORATORY TECHNICIANS WERE SPLASHED IN THE FACE. DURING DAILY MAINTENANCE PROCEDURE AFTER PROCESSING SAMPLES, IT IS WAS INDICATED TO RINSE THE WASTE CHUTE UNDER RUNNING WATER TO PREVENT THE ACCUMULATION OF IRON MICROPARTICLES. HOWEVER, IN THIS INSTANCE, AN UNTRAINED USER PERFORMED THIS MAINTENANCE IN THE LABORATORY SINK WITHOUT PROPERLY CONTROLLING THE WATER PRESSURE, CAUSING WATER TO SPLASH ONTO HER FACE. THE USER REPORTED FEELING WATER DROPLETS IN HER MOUTH, AS SHE WAS NOT WEARING A FACE MASK OR PROTECTIVE EYEWEAR AT THE TIME. DUE TO THE NATURE OF THE SAMPLES PROCESSED IN THIS LABORATORY (HIV SAMPLES), SHE EXPRESSED CONCERN ABOUT POTENTIAL RISKS ASSOCIATED WITH THIS EXPOSURE. THE TECHNICAL APPLICATION SPECIALIST (TAS) INFORMED THE CUSTOMER THAT REGARDING THE AUTOMATED INSTRUMENT'S PROCESS OF M2000SP, THE SAMPLES GO THROUGH AN EXTRACTION PHASE WHERE VIRAL RNA IS ISOLATED, AND RESIDUAL COMPONENTS, INCLUDING IRON-BASED MAGNETIC PARTICLES USED IN THE EXTRACTION PROCESS, ARE WASHED AWAY. WHILE TRACE AMOUNTS OF THESE PARTICLES MAY REMAIN IN THE WASTE CHUTE BEFORE RINSING, THEIR PRESENCE IN SIGNIFICANT CONCENTRATIONS AFTER THE CLEANING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21609372 ↗
• MalfunctionMar 14, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  WHILE CLEANING THE WASTE CHUTE OF THE M2000SP, TWO LABORATORY TECHNICIANS WERE SPLASHED IN THE FACE. DURING DAILY MAINTENANCE PROCEDURE AFTER PROCESSING SAMPLES, IT IS WAS INDICATED TO RINSE THE WASTE CHUTE UNDER RUNNING WATER TO PREVENT THE ACCUMULATION OF IRON MICROPARTICLES. HOWEVER, IN THIS INSTANCE, AN UNTRAINED USER PERFORMED THIS MAINTENANCE IN THE LABORATORY SINK WITHOUT PROPERLY CONTROLLING THE WATER PRESSURE, CAUSING WATER TO SPLASH ONTO HER FACE. THE USER REPORTED FEELING WATER DROPLETS IN HER MOUTH, AS SHE WAS NOT WEARING A FACE MASK OR PROTECTIVE EYEWEAR AT THE TIME. DUE TO THE NATURE OF THE SAMPLES PROCESSED IN THIS LABORATORY (HIV SAMPLES), SHE EXPRESSED CONCERN ABOUT POTENTIAL RISKS ASSOCIATED WITH THIS EXPOSURE. THE TECHNICAL APPLICATION SPECIALIST (TAS) INFORMED THE CUSTOMER THAT REGARDING THE AUTOMATED INSTRUMENT'S PROCESS OF M2000SP, THE SAMPLES GO THROUGH AN EXTRACTION PHASE WHERE VIRAL RNA IS ISOLATED, AND RESIDUAL COMPONENTS, INCLUDING IRON-BASED MAGNETIC PARTICLES USED IN THE EXTRACTION PROCESS, ARE WASHED AWAY. WHILE TRACE AMOUNTS OF THESE PARTICLES MAY REMAIN IN THE WASTE CHUTE BEFORE RINSING, THEIR PRESENCE IN SIGNIFICANT CONCENTRATIONS AFTER THE CLEANING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21609322 ↗
• MalfunctionOct 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED LIQUID LEAK IN THE SYSTEM SOLUTIONS DRAWER OF THE ALINITY M SYSTEM. THE LEAK FROM LIQUID WASTE HAD REACHED THE FLOOR AND WENT BEYOND THE FOOTPRINT ON THE INSTRUMENT. PHOTOS OF LEAK WAS NOT PROVIDED. LABORATORIANS WERE WEARING APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE) AT THE TIME OF THE LEAK AND DURING CLEAN UP. THERE WAS NO REPORT OF CONTACT WITH THE LIQUID LEAK. NO INJURIES OCCURRED AS A RESULT OF THE LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20528757 ↗
• MalfunctionSep 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A LEAK ON THE ALINITY M SYSTEM SN (SERIAL NUMBER) (B)(6). THE CUSTOMER REPORTED THAT THEIR ALINITY M SYSTEM IS LEAKING ETHANOL. THE LIQUID REACHED THE FRONT OF THE SYSTEM AND WAS OUTSIDE THE FOOTPRINT OF THE INSTRUMENT. THE LEAK WAS CLEANED BY THE CUSTOMER USING PROPER PPE (PERSONAL PROTECTIVE EQUIPMENT). THERE WAS NO EXPOSURE TO THE LIQUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20245921 ↗
• MalfunctionAug 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A LEAK ON THE RIGHT SIDE OF THEIR ALINITY M INSTRUMENT. THE CUSTOMER NOTICED A LEAK COMING FROM UNDER THE RIGHT SIDE OF THE INSTRUMENT, A SMALL AMOUNT OF CRYSTALLIZATION BUILDUP UNDER THE LYSIS CRADLE, AND SOME EXTRA LIQUID WASTE IN THE SOLID WASTE BIN. THE CUSTOMER CHECKED THE SYSTEMS SOLUTIONS DRAWER BEFORE CALLING AND DID NOT NOTICE ANY DAMAGE TO THE LIQUID WASTE BOTTLES OR ANY TUBING IN THE DRAWER. THE CUSTOMER STATED THAT THE LIQUID POOL WAS ABOUT 12 INCHES IN DIAMETER AND LEFT THE FOOTPRINT OF THE INSTRUMENT. THE CUSTOMER CLEANED THE SPILL WITH PAPER TOWELS. THE FIELD SERVICE ENGINEER (FSE) PERFORMED TROUBLESHOOTING AND REPLACED THE ELUTION VAPOR BARRIER RESERVOIR SENSOR AND THE LYSIS CRADLE. THE FSE INSPECTED AND CLEANED THE LIQUID WASTE EXTRACTION NOZZLES TO REMOVE ANY BUILDUP AND BLOCKAGES. THERE WAS NO INJURY TO THE CUSTOMER FROM THE LEAK. THE CUSTOMER CLEANED THE LEAK WITH PERSONAL PROTECTIVE EQUIPMENT (PPE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19976029 ↗
• MalfunctionAug 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A LEAK OF DILUENT SOLUTION OR LIQUID WASTE FROM THE SYSTEM SOLUTIONS DRAWER FROM THE ALINITY M INSTRUMENT. THE CUSTOMER REPORTED THAT THE LEAK HAD SPREAD BEYOND THE FOOTPRINT OF THE INSTRUMENT. THE CUSTOMER REPORTED ERROR 5020: SYSTEM SOLUTION (DILUENT) TRANSFER ERROR FOLLOWED BY ERROR 2162: TRANSFERRING FOR SYSTEM SOLUTION DISABLED ON ATTEMPTING POWER CYCLE. CUSTOMER ADVISED TO CLEAN UP THE SPILLAGE AND DISCONTINUE USE OF THE INSTRUMENT. CUSTOMER REPORTED NO EXPOSURE TO HAZARDOUS MATERIAL AS A RESULT OF THE LEAK, AND PERSONAL PROTECTIVE EQUIPMENT (PPE) WAS WORN AS PER NORMAL LABORATORY PROCEDURES. NO INJURIES WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19908675 ↗
• InjuryJul 2, 2024Human-Device Interface Problem; Human-Device Interface Problem

  THE CUSTOMER REPORTED A SERIOUS INJURY/ADVERSE EVENT OCCURRED ON THEIR M2000SP SYSTEM. THE CUSTOMER REPORTED THAT WHILE PERFORMING THE DAILY MAINTENANCE ON THEIR M2000SP, THE WASTE CHUTE FELL AND CUT THEIR FINGER. THE CUSTOMER CONFIRMED THAT THEY WERE WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) (GLOVES, FACE MASK, LAB COAT, ETC.). THEY IMMEDIATELY WASHED THEIR HAND WITH TAP WATER. MEDICAL SERVICES WERE CONTACTED FOR TREATMENT OF THE INJURY AND FOR THE PREP (PREEXPOSURE PROPHYLAXIS) TREATMENT FOR HIV-1 ACCORDING TO THE COUNTRY REGULATIONS.

  Patient problems: Abrasion

  MAUDE report 19656366 ↗
• MalfunctionJun 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A LEAK FROM THEIR LIQUID WASTE CONTAINER ON THEIR M2000SP SYSTEM. THE CUSTOMER REPORTED A LEAK FROM THEIR LIQUID WASTE CONTAINER. THE LEAK WAS UNDER THE INSTRUMENT AND ON THE FLOOR IN FRONT OF THE INSTRUMENT. THE LEAK WAS OCCURRING FROM THE CONNECTOR ON THE CONTAINER LID OF THE LIQUID WASTE CONTAINER. THE CUSTOMER REPORTED THAT THEY COULD SEE THAT THE RUBBER ON THE CONNECTOR WAS BREAKING. THE CUSTOMER REPORTED THAT THEY WORE APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE) TO CLEAN UP THE LEAK. A TECHNICAL APPLICATION SPECIALIST (TAS) ORDERED A NEW LIQUID WASTE ASSEMBLY FOR THE CUSTOMER. THE CUSTOMER WAS ABLE TO INSTALL THE CORRECT PARTS AND CONTINUE TO UTILIZE THE INSTRUMENT. THE INSTRUMENT WAS PERFORMING PER SPECIFICATION AND THE CUSTOMER ACCEPTED THE INSTRUMENT FOR ROUTINE USE. THERE WAS NO REPORT OF INJURY OR ACTUAL EXPOSURE TO THE LEAK. THERE WAS NO PATIENT INVOLVEMENT AS THE LEAK WAS IDENTIFIED BY THE M2000SP SYSTEM USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19575546 ↗
• MalfunctionFeb 1, 2024Human-Device Interface Problem; Human-Device Interface Problem

  THE CUSTOMER CALLED TO REPORT A USER OF THE M2000SP HAD SUSTAINED A VERY SMALL (NEEDLE STICK LIKE) PUNCTURE WOUND TO THE FINGER THROUGH THE PPE (PERSONAL PROTECTIVE EQUIPMENT) GLOVE. THE OPERATOR RECEIVED A SMALL CUT FROM THE SHARP CENTRAL PART OF THE PIPETTOR WHILST CLEANING WITH ETHANOL. THE CUSTOMER CONFIRMED THAT THE PART OF THE PIPETTOR WOULD BE WITHIN THE AREA COVERED ABOVE THE FILTER WHEN A TIP IS FIXED, AND THAT DAILY MAINTENANCE/CLEANING IS ALWAYS CARRIED OUT. THE CUSTOMER EXPLAINED THAT THE INDIVIDUAL WHO HAD THE SMALL CUT (CLARIFIED AS MORE OF A "SCRATCH") RECEIVED STANDARD FIRST AID (WOUND CLEANING/FORCED BLEEDING) AND THEN IMMEDIATELY VISITED THE HOSPITAL WHERE THE CUSTOMER IS BASED. THE CUSTOMER EXPLAINED THAT THE RUN PERFORMED IMMEDIATELY BEFORE THE INCIDENT WAS FOR HIV SAMPLES. BEFORE TREATMENT ROUTE WAS DECIDED FOR THE USER WITH PUNCTURE WOUND, THE RESULTS OF THIS RUN WERE TO CHECKED. THIS RUN, PREVIOUS TO THE EVENT, DID INCLUDE POSITIVE SAMPLES. THE CUSTOMER CANNOT CURRENTLY CONFIRM BUT BELIEVES THAT ANTIRETROVIRAL TREATMENT HAS BEEN GIVEN TO THE USER WHO SUSTAINED A PUNCTURE WOUND AS A PRECAUTIONARY MEASURE AND AS POSTEXPOSURE PROPHYLAXIS. EVALUATION WILL BE RUN

  Patient problems: Abrasion

  MAUDE report 18627238 ↗
• MalfunctionNov 7, 2022Leak/Splash; Leak/Splash

  DURING DE-INSTALLATION OF M2000SP SN (B)(4) (094094RE1851352), AN ABBOTT FIELD SERVICE ENGINEER (FSE) HAD A LIQUID SPLASH ON HIS EYES FROM THE WASTE TUBING.. THE FSE WAS WEARING GLASSES. THE FSE CLEANED HIS EYES AFTER THE SPLASH. THE INSTRUMENT WAS NOTED TO ONLY HAVE BEEN USED TO RUN THE HCV GENOTYPE ASSAY. THE FSE HAS NOT BEEN GIVEN ANY THERAPY OUTSIDE OF BASIC FIRST AID; THE FSE PROVIDED A SAMPLE FOR BLOOD ANALYSIS WHICH SHOWS NEGATIVE RESULTS IN ALL TESTED PATHOGENS. THE FSE IS NOTED TO BE DOING WELL WITH NO SIGNS OF INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15749551 ↗
• MalfunctionAug 26, 2022Leak/Splash; Use of Device Problem; Leak/Splash; Use of Device Problem

  THE CUSTOMER REPORTED THAT WHILE CLEANING THE SYSTEM LIQUID WASTE BOTTLE ON THE M2000SP (09K14-02) INSTRUMENT SERIAL NUMBER: (B)(4), SOME LIQUID SPLASHED INTO THE TECHNICIAN'S EYE. THE TECHNICAL APPLICATION SPECIALIST (TAS) ADVISED THE AFFECTED PERSON TO WASH THEIR EYE THOROUGHLY USING A EYE-WASH FOR 15 MINUTES AND ALSO ADVISED CUSTOMER TO IMMEDIATELY CALL THE WORK DOCTOR TO ARRANGE FOR A POST-EXPOSURE PROPHYLAXIS. THE CUSTOMER WHO HAD BEEN IN CONTACT WITH THE LIQUID WASTE HAS CONSULTED THE DOCTOR AND IS UNDER POST EXPOSURE PROPHYLAXIS TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15302946 ↗
• MalfunctionSep 13, 2021Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED A LEAK ON A REALTIME M2000SP INSTRUMENT. THE CUSTOMER REPORTED THERE WAS A KINK IN THE TUBING OF THE LIQUID WASTE LINE PREVENTING IT FROM FLOWING INTO THE LIQUID WASTE CONTAINER. THE LINE BACKED UP AND OVERFLOWED ONTO THE WORKTABLE. THE SPILL REACHED THE WALKING SURFACE. THE CUSTOMER CLEANED THE LEAK WHILE WEARING APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE). THERE WAS NO ACTUAL EXPOSURE OR INJURY ASSOCIATED WITH THE EVENT. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED IN (B)(6) USING THE M2000SP INSTRUMENT, LIST 09K14-02, WHICH IS ALSO US FDA APPROVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12464307 ↗
• MalfunctionSep 13, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THERE WAS A LEAK UNDER THE INSTRUMENT OF THE WASTE TRAY OF THEIR M2000SP INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12463167 ↗
• MalfunctionAug 3, 2020Device Damaged Prior to Use; Device Damaged Prior to Use

  THIRD PARTY DISTRIBUTOR RECEIVED A SHIPMENT OF M2000 REAGENT VESSELS. UPON RECEIPT OF THE BOXES, THEY REALIZED THAT ONE OF THE CARDBOARD BOXES HAD BROKEN, AND INSIDE THE BOX ONE PACKAGE OF REAGENT VESSELS HAD BROKEN, EXPOSING A SHARP EDGE. THIS BOX HAS BEEN QUARANTINED AT THE DISTRIBUTOR WAREHOUSE AND HAS NOT BEEN SENT TO THE END USER CUSTOMER. NO INJURIES WERE SUSTAINED WHEN THE BOX WAS OPEN OR WHEN THE BROKEN REAGENT VESSEL WAS HANDLED. A TOTAL OF 5 PACKETS OF REAGENT VESSELS WERE BROKEN. THERE IS NO PATIENT INVOLVED AS THE BROKEN REAGENT VESSELS WERE IDENTIFIED BY A THIRD PARTY DISTRIBUTOR. ACCORDING TO THE M2000SP OPERATIONS MANUAL (200681-109 - MARCH 2016), UP TO SIX 200 ML REAGENT VESSELS HOLD THE SAMPLE PREPARATION REAGENTS NEEDED FOR AUTOMATED SAMPLE PREPARATION ON THE M2000SP INSTRUMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10359319 ↗
• MalfunctionJul 22, 2020Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED THE LIQUID WASTE TUBING ON HER M2000SP INSTRUMENT TO BE CRACKED AND LEAKING. CUSTOMER STATED THAT LIQUID HAD LEAKED TO THE FLOOR AS THE INSTRUMENT WAS RUNNING AND THE TUBING HAS CRACKED. THE CUSTOMER DECONTAMINATED THE SYSTEM WASTE CABINET DRAWER AS WELL AS CONTAINED THE SPILL ON THE FLOOR BY CLEANING AND DECONTAMINATING. NO INJURIES AND NO EXPOSURE OCCURRED IN ASSOCIATION WITH THE LEAK. THE CUSTOMER SUCCESSFULLY CLEANED UP THE SMALL PUDDLE IN FRONT OF THE INSTRUMENT. FIELD SERVICE ENGINEER REPLACED THE LIQUID WASTE TUBING BETWEEN THE LIQUID WASTE BOTTLE AND WASTE STATION NOZZLES. NO ISSUE OF LEAKS HAVE BEEN OBSERVED SINCE SERVICE WAS PERFORMED. NO PATIENT WAS INVOLVED AS THIS OBSERVATION WAS MADE BY THE M2000SP USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10311058 ↗
• MalfunctionJun 22, 2020Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTED THE LIQUID WASTE CONNECTOR ON THEIR M2000SP INSTRUMENT WAS NOT WORKING AS EXPECTED, WHICH CAUSED DRIPPING. LEAKAGE OCCURRED OUTSIDE THE INSTRUMENT AND REACHED THE WALKING SURFACE. THE CUSTOMER DIDN'T GET IN CONTACT WITH THE LIQUID AND PERSONAL PROTECTIVE EQUIPMENT WERE USED BY THE LAB PERSONNEL. THERE WAS NO INJURY ASSOCIATED WITH THIS OBSERVATION. LOCAL ENGINEER CONFIRMED THE CUSTOMER HAD NO FURTHER ISSUES. DISCUSSED POSSIBLE CAUSES SUCH AS A NOT FULLY CONNECTED WASTE CONNECTOR. CUSTOMER IS THEN SATISFIED AND THEREFORE NO FURTHER ACTIONS ARE REQUIRED. NO PATIENT WAS INVOLVED AS THIS OBSERVATION WAS MADE BY THE M2000SP USER. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED IN (B)(4) USING THE M2000SP INSTRUMENT, LIST 9K14-02, WHICH IS ALSO US FDA APPROVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10182039 ↗
• MalfunctionJul 30, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED FLUID LEAKAGE FROM THE M2000SP INSTRUMENT. THE LEAK OCCURRED WHILE THE INSTRUMENT WAS PERFORMING AN EXTENSIVE FLUSH DURING A MAINTENANCE PROCEDURE. THE FLUID DRIPPED INSIDE THE SOLID WASTE CONTAINER. WHEN OPENING THE WASTE DRAWER, A SMALL PATCH OF LIQUID REACHED THE WALKING SURFACE. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), AND THEY DID NOT COME IN DIRECT CONTACT WITH THE LIQUID. THERE WAS NO INJURY REPORTED RELATED TO THE EVENT. THE FIELD SERVICE ENGINEER (FSE) REPORTED THAT THE HOSE CLIP FASTENING THE WASTE TUBE WAS LOOSE ALLOWING FLUID TO PASS OUT OF THE TUBE. THE CLIP ALSO SHOWED EXTENSIVE CORROSION, AND THE WASTE TUBE WAS DISCOLORED. THE WASTE TUBING WAS REPLACED WITH A NEW HOSE CLIP. ALL VERIFICATIONS PERFORMED AND PASSED. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED IN (B)(6) USING THE M2000SP INSTRUMENT, LIST NUMBER 09K14-02 WHICH IS ALSO APPROVED FOR USE IN THE UNITED STATES.

  Patient problems: No Patient Involvement

  MAUDE report 8843380 ↗
• MalfunctionFeb 20, 2019Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED AN INCIDENT THAT A LAB TECHNICIAN WAS DISPOSING THE RED HAZARDOUS BAG FROM THE M2000SP INSTRUMENT TO THEIR WASTE BAG FOR HAZARDOUS GOODS TO BE SENT FOR INCINERATION, AND A TIP RIPPED THROUGH THE RED BAG AND HER GLOVES WHICH CUT HER FINGER. THE CUSTOMER STATED THAT THE LAB TECHNICIAN WAS TAKING OUT THE SOLID WASTE BAG AND TRANSFERRING IT TO ANOTHER BAG. THE TECHNICIAN PUSHED DOWN ON THE BAG, WHICH CAUSED THE PUNCTURE OF THE TIP THROUGH THE BAG AND THE TECHNICIAN'S GLOVE. THEY WERE TESTING (B)(6) SAMPLES. THE CUSTOMER REPORTED IT WAS A SUPERFICIAL SCRATCH ON THEIR FINGER, AND THERE WAS EVIDENCE OF BLOOD. THE CUSTOMER COMPLETED AN INTERNAL INVESTIGATION OF THEIR PROCESS FOR WASTE DISPOSAL. THE CUSTOMER BELIEVED IT WAS AN INTERNAL HANDLING ISSUE RATHER THAN AN INCIDENT CAUSED BY AN ABBOTT PRODUCT DEFICIENCY. THE CUSTOMER HAS SINCE CHANGED THEIR INTERNAL PRACTICE FOR SOLID WASTE DISPOSAL. THE CUSTOMER BLAMES INTERNAL WASTE HANDLING AND NOT ABBOTT FOR THIS REPORTED INCIDENT. THE LAB TECHNICIAN WENT TO OCCUPATIONAL HEALTH, AND TESTING AND PRECAUTIONS WERE COMPLETED. THE CUSTOMER STATED THAT THE AFFECTED USER RECEIVED (B)(6) PROPHYLAXIS, HBV BOOSTER INJECTION, AND BAS

  Patient problems: Abrasion

  MAUDE report 8354169 ↗
• MalfunctionOct 15, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE ABBOTT M2000 SYSTEM IS INTENDED FOR USE IN PERFORMING NUCLEIC ACID TESTING IN CLINICAL LABORATORIES. IT IS COMPRISED OF THE ABBOTT M2000SP AND THE ABBOTT M2000RT INSTRUMENTS. THE ABBOTT M2000SP IS AN AUTOMATED SYSTEM FOR PERFORMING SAMPLE PREPARATION FOR NUCLEIC ACID TESTING. THE ABBOTT M2000RT IS AN AUTOMATED SYSTEM FOR PERFORMING FLUORESCENCE-BASED PCR TO PROVIDE QUANTITATIVE AND QUALITATIVE DETECTION OF NUCLEIC ACID SEQUENCES. THE CUSTOMER REPORTED THAT THE M2000SP INSTRUMENT HAD LEAKAGE FROM THE WASTE TUBE. THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LOCATION. THE FSE PERFORMED AN INSPECTION OF THE WASTE TUBING. THE WASTE TUBE HAD A CRACK WHERE LIQUID WASTE POURED OUT IN THE BACK OF THE M2000SP INSTRUMENT CABINET, AND THE FSE REPORTED THERE WAS FLUID ON THE FLOOR. THE CUSTOMER WORE GLOVES AND A LAB COAT WHILE CLEANING UP THE FLUID. THE FSE REPLACED THE WASTE TUBE AND COMPLETED A FLUSH OF THE WASTE TUBE WHILE LOOKING AND MOVING THE WASTE TUBING SYSTEM. ALL CHECKS AND CALIBRATIONS PASSED, THE INSTRUMENT WAS WORKING PER SPECIFICATION, AND NO FURTHER ACTION WAS REQUIRED. THE CUSTOMER ACCEPTED THE INSTRUMENT FOR ROUTINE USE. THIS MEDICAL DEVICE REPORT (MDR)

  Patient problems: No Patient Involvement

  MAUDE report 7965057 ↗
• InjuryAug 28, 2018Human-Device Interface Problem; Human-Device Interface Problem

  THE ABBOTT M2000 SYSTEM IS INTENDED FOR USE IN PERFORMING NUCLEIC ACID TESTING IN CLINICAL LABORATORIES. IT IS COMPRISED OF THE ABBOTT M2000SP AND THE ABBOTT M2000RT INSTRUMENTS. THE ABBOTT M2000SP IS AN AUTOMATED SYSTEM FOR PERFORMING SAMPLE PREPARATION FOR NUCLEIC ACID TESTING. THE ABBOTT M2000RT IS AN AUTOMATED SYSTEM FOR PERFORMING FLUORESCENCE-BASED PCR TO PROVIDE QUANTITATIVE AND QUALITATIVE DETECTION OF NUCLEIC ACID SEQUENCES. THE CUSTOMER STATES THAT THEIR MASTER MIX ADDITION RUN FOR HIV-1 ROUTINE ENDED NORMALLY. THE CUSTOMER TRIED TO LIFT THE AMPLIFICATION REAGENT PACKS FROM THE ASSAY REAGENT HOLDER ON THE OUTPUT DECK OF THE M2000SP INSTRUMENT TO DISCARD THEM, BUT THE PACKS DIDN'T COME OUT EASILY, SO THE CUSTOMER APPLIED MORE FORCE TO DO SO. AT ONE TIME WHILE LIFTING, THE CUSTOMER COULDN´T TAKE THE AMPLIFICATION PACK, AND HER HAND CRASHED WITH THE ROBOTIC MANIPULATOR ARM (ROMA), RESULTING IN TEARING OF THE GLOVE AND A CUT ON THE KNUCKLES WITH BLOOD. AFTER THAT, THE CUSTOMER TRIED TO CLEAN THE BLOOD FROM THE ARM, BUT SHE CUT HER INDEX FINGER (WHILE USING GLOVES), REPORTING THE EDGE OF THE ARM IS SHARP. THE CUSTOMER WASHED HER INJURIES FOR 30 MINUTES WITH WATER AND SOAP. CUS

  Patient problems: Abrasion

  MAUDE report 7825190 ↗
• MalfunctionAug 13, 2018Circuit Failure; Circuit Failure

  THE ABBOTT M2000 SYSTEM IS INTENDED FOR USE IN PERFORMING NUCLEIC ACID TESTING IN CLINICAL LABORATORIES. IT IS COMPRISED OF THE ABBOTT M2000SP AND THE ABBOTT M2000RT INSTRUMENTS. THE ABBOTT M2000SP IS AN AUTOMATED SYSTEM FOR PERFORMING SAMPLE PREPARATION FOR NUCLEIC ACID TESTING. THE ABBOTT M2000RT IS AN AUTOMATED SYSTEM FOR PERFORMING FLUORESCENCE-BASED PCR TO PROVIDE QUANTITATIVE AND QUALITATIVE DETECTION OF NUCLEIC ACID SEQUENCES. CUSTOMER CALLED TO REPORT RECEIPT OF AN ERROR CODE 3205 "THE DILUTORS ARE NOT IMPLEMENTED DEVICES." DURING DAILY MAINTENANCE ON THE M2000SP, THE LAB TECHNICIAN HEARD A LOUD BANG AND THE LIHA WAS FROZEN MID-AIR (BUT DOESN'T SEEM TO HAVE HIT ANYTHING). AFTER CYCLING POWER, THE LIHA WAS STILL NOT MOVING AND COMPUTER WAS FROZEN. LOCAL FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE SOURCED THE FAULT TO A BLOWN FUSE #2 LOCATED ON THE OPTIBO BOARD AND ALSO DILUTOR #1 HAD FAILED DUE TO A DAMAGED CAPACITOR ON THE PRINTED CIRCUIT BOARD (PCB). FSE REPLACED THE FUSE AND DILUTOR #1, WHICH RESOLVED THE ISSUE. ALL INSTRUMENT CHECKS, TESTS AND VERIFICATIONS SUCCESSFULLY PASSED AS PER LATEST ABBOTT SERVICE MANUAL AND THE INSTRUMENT WAS RETURNED TO THE CUSTOMER FO

  Patient problems: No Patient Involvement

  MAUDE report 7778663 ↗
• MalfunctionJul 17, 2018Circuit Failure; Circuit Failure

  THE ABBOTT M2000 SYSTEM IS INTENDED FOR USE IN PERFORMING NUCLEIC ACID TESTING IN CLINICAL LABORATORIES. IT IS COMPRISED OF THE ABBOTT M2000SP AND THE ABBOTT M2000RT INSTRUMENTS. THE ABBOTT M2000SP IS AN AUTOMATED SYSTEM FOR PERFORMING SAMPLE PREPARATION FOR NUCLEIC ACID TESTING. THE ABBOTT M2000RT IS AN AUTOMATED SYSTEM FOR PERFORMING FLUORESCENCE-BASED PCR TO PROVIDE QUANTITATIVE AND QUALITATIVE DETECTION OF NUCLEIC ACID SEQUENCES. CUSTOMER REPORTED THAT THEIR M2000SP INSTRUMENT REMAINED OFFLINE. A FIELD SERVICE ENGINEER WENT ON SITE AND FOUND EVIDENCE OF OVERHEATING/CHARRING ON THE PCBA (PRINTED CIRCUIT BOARD ASSEMBLY). ELEVATED COMPLAINT INVESTIGATION HAS BEEN OPENED. NO PATIENT WAS INVOLVED. THE OBSERVATION WAS MADE BY AN ABBOTT MOLECULAR FIELD SERVICE ENGINEER. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED IN (B)(6) USING THE M2000SP INSTRUMENT, LIST NUMBER 09K14-02 WHICH IS ALSO APPROVED FOR USE IN THE UNITED STATES.

  Patient problems: No Patient Involvement

  MAUDE report 7696598 ↗
• InjuryFeb 13, 2017Device Handling Problem; Device Handling Problem

  THE ABBOTT M2000 SYSTEM IS INTENDED FOR USE IN PERFORMING NUCLEIC ACID AMPLIFICATION TESTING BY POLYMERASE CHAIN REACTION IN CLINICAL LABORATORIES. THE SYSTEM IS COMPOSED OF THE M2000RT AND THE M2000SP INSTRUMENTS. THE M2000SP IS INTENDED FOR AUTOMATED SAMPLE PREPARATION AND NUCLEIC ACID EXTRACTION PRIOR TO TESTING. CUSTOMER REPORTED ONE OF THE TUBING CONNECTORS FROM THE TOP OF THE LIQUID WASTE CONTAINER WAS BROKEN. THE FIELD SERVICE ENGINEER (FSE) FROM THE DISTRIBUTOR WENT ON SITE TO ASSESS THE SITUATION. ON SITE, THE FSE CONFIRMED THAT THE WHITE MALE CONNECTION WAS BROKEN. FSE REMOVED THE LIQUID WASTE CONTAINER, EMPTIED THE WASTE, RINSED WITH WATER, THEN CLEANED WITH 2% BLEACH, AND THEN RE-RINSED WITH WATER. FSE THEN CHANGED THE WASTE TUBING OF THE WHITE MALE CONNECTOR. TO CHANGE THE WASTE TUBING, THE FSE TRIED CUTTING THE TUBING WITH A KNIFE TO CHANGE THE CONNECTOR. THE KNIFE SLIPPED AND THE FSE CUT HERSELF IN ONE FINGER. SHE WAS WEARING GLOVES WHEN THIS OCCURRED, BUT A SLIGHT SCRAPE WAS CREATED ON ONE OF HER FINGERS. THE FSE CONTACTED TWO PHYSICIANS. ONE OF THEM DID NOT RECOMMEND STARTING A TREATMENT SINCE THE CUT WAS VERY LIGHTLY DONE; THE OTHER ONE RECOMMEND STARTING AN ANTIR

  Patient problems: No Patient Involvement

  MAUDE report 6327579 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092705. One submission often covers many models, so check the product and lot details in each record.

• Z-0463-2015 · Oct 23, 2014 · Terminated
  Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
• Z-2169-2014 · Jun 19, 2014 · Terminated
  5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System). The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplific
• Z-0948-2015 · Nov 23, 2013 · Terminated
  The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.
• Z-0634-2013 · Dec 4, 2012 · Terminated
  Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m
• Z-2013-2012 · Jan 31, 2012 · Terminated
  Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up the Bar Code Scanner LN 6L89-01, a component of the Abbott m2000 Instrument System; Abbott Molecular Inc
• Z-0365-2012 · Oct 11, 2011 · Terminated
  Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14
• Z-0048-2012 · Sep 8, 2011 · Terminated
  Abbott m2000rt System software; an automated system for performing fluorescence-based PCR that results in quantitative and qualitative detection of nucleic acid sequences; Abbott M