Panther® PANTHER, INSTRUMENT SYSTEMRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 15420045504141), received between Nov 29, 2017 and Jul 28, 2026 — classified as 14 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2026Device Contaminated at the User Facility

  Patient problems: Eye Irritation; Headache; Sore Throat; Upper Respiratory Tract Irritation

  MAUDE report 50061395 ↗
• MalfunctionJul 27, 2026Device Contaminated at the User Facility

  On July 8, 2026, customer reported that they observed black-colored dust in the waste drawer of their Panther Plus instrument (serial number (b)(6)) following maintenance. Upon inspecting the instrument, customer reported that the vacuum filter was improperly installed several months prior. No harm, injury, or incorrect results were reported as a result of the black dust. Hologic has not been informed of any adverse outcomes related to this issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50020089 ↗
• InjuryMar 17, 2026Patient Device Interaction Problem

  ON FEBRUARY 23, 2026, HOLOGIC SALES REPORTED ON BEHALF OF A CUSTOMER THAT ON (B)(6) 2026, AN OPERATOR INJURED THEIR BACK WHILE HANDLING THE LIQUID WASTE BOTTLE ON THE PANTHER INSTRUMENT (SN: (B)(6)). DUE TO THE INJURY, THE OPERATOR REQUIRED MEDICAL ATTENTION AND WAS REPORTED TO BE OUT FOR SEVERAL WEEKS. CUSTOMER REQUESTED THE WEIGHT OF THE PANTHER LIQUID WASTE BOTTLE WHEN FULL. THE MAXIMUM WEIGHT EXPECTATION FOR A FULL PANTHER LIQUID WASTE CONTAINER SHOULD NOT EXCEED 20 LBS. AND WAS MEASURED TO BE 14.6 POUNDS DURING PANTHER VERIFICATION TESTING. CUSTOMER DID NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24619545 ↗
• MalfunctionMar 13, 2026Missing Test Results

  ON (B)(6) 2026, CUSTOMER REPORTED THAT THEY WERE UNABLE TO LOCATE THE RESULTS FOR A RACK OF SAMPLES TESTED ON (B)(6) 2026, ON THE PANTHER FUSION PLUS INSTRUMENT (SN (B)(6). ON (B)(6) 2026, CUSTOMER STATED THAT SAMPLES IN RACK 589-01 IN WORKLIST (WL) (B)(4) HAD INCORRECT SAMPLE IDS THAT BELONGED TO SAMPLES THAT WERE NOT PIERCED. (SID) (B)(6) WAS REPORTED OUT AS CT POSITIVE/GC NEGATIVE AND WAS LATER RETESTED AS NEGATIVE ON (WL) (B)(4) AND AMENDED TO CT NEGATIVE / GC NEGATIVE. ALL OTHER (SIDS) IN THE AFFECTED RACK 589-01 HAD THE SAME RESULT UPON RETESTING IN (WL) (B)(4) AND REMAINED CT NEGATIVE/GC NEGATIVE. ON FEBRUARY 13TH AND 14TH 2026, HOLOGIC TECHNICAL SUPPORT REVIEWED THE LOGS AND NOTICED THERE WERE MULTIPLE ERROR MESSAGES RELATED TO THE RACK ID BARCODES OR POSITIONAL BARCODES NOT READING OR MISSING ON SAMPLE RACKS. ON (B)(6) 2026, CUSTOMER REPORTED THAT THEY USED NEW SAMPLE RACKS AND CONTINUED TO HAVE LOADING ISSUES. TECHNICAL SUPPORT REVIEWED LOGS AND CONFIRMED THAT THERE WERE MULTIPLE MESSAGES: ¿SAMPLE RACK IN LANE 1 WAS REJECTED DUE TO MISSING POSITIONAL BARCODE AT POSITION 1¿. TECHNICAL SUPPORT NOTED THAT THE ISSUE IS MOST LIKELY DUE TO THE OPERATOR NOT PUSHING THE RACK IN P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24591021 ↗
• MalfunctionJan 26, 2026Power Problem

  ON DECEMBER 31, 2025, CUSTOMER REPORTED THAT A BURNING SMELL WAS COMING FROM THEIR PANTHER PLUS INSTRUMENT SN (B)(6). CUSTOMER REPORTED THEY WERE NOT ABLE TO PINPOINT THE SOURCE BUT POWERED OFF AND UNPLUGGED THE INSTRUMENT WHILE AWAITING HOLOGIC SERVICE. NO HARM OR INJURY WAS REPORTED AS A RESULT OF THE BURNING SMELL. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE OUTCOMES RELATED TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177777 ↗
• MalfunctionJan 16, 2026Unexpected Shutdown

  ON (B)(6) 2025, CUSTOMER REPORTED THAT A BURNING SMELL WAS COMING FROM THEIR PANTHER FUSION INSTRUMENT SN (B)(6), FOLLOWING A HARDWARE ERROR AND UNEXPECTED INSTRUMENT SHUTDOWN. CUSTOMER REPORTED THEY WERE NOT ABLE TO POWER BACK UP THE INSTRUMENT. NO HARM OR INJURY WAS REPORTED AS A RESULT OF THE BURNING SMELL. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE OUTCOMES RELATED TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24104577 ↗
• InjurySep 2, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2025, A CUSTOMER REPORTED THAT WHILE CHANGING THE LIQUID WASTE ON THE PANTHER FUSION PLUS INSTRUMENT (B)(6), AN OPERATOR BUMPED THE PANTHER BLEACH BOTTLE ON A COUNTERTOP AND ACCIDENTALLY SPLASHED BLEACH UP INTO THEIR EYE. OPERATOR WAS NOT WEARING EYE PROTECTION AT THE TIME AND IMMEDIATELY FLUSHED THE EYE WITH WATER. CUSTOMER REPORTED THERE WERE NO INJURIES AND THE AFFECTED OPERATOR HAD NO SUBSEQUENT ISSUES WITH THE IMPACTED EYE. HOLOGIC HAS NOT LEARNED OF ANY FURTHER TREATMENT OR ADVERSE OUTCOMES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22947045 ↗
• MalfunctionAug 15, 2025Flare or Flash; Flare or Flash

  ON JULY 16, 2025, A CUSTOMER REPORTED THAT A WATER PIPE BURST OVER THE TOP OF THEIR PANTHER IN THEIR LAB, CAUSING WATER TO GET INSIDE THEIR PANTHER (SN (B)(6)). THE PANTHER'S POWER SUPPLY SHORT CIRCUITED, WITH CUSTOMER REPORTING THAT THEY OBSERVED SMOKE AND SPARKS THAT TURNED INTO A ¿MINI FIRE¿ THAT EXTINGUISHED ITSELF. CUSTOMER UNPLUGGED THE POWER CORD FOR THE PANTHER AND NO FURTHER ACTIONS WERE REQUIRED. THERE WERE NO REPORTS OF INJURIES OR HEALTH CONCERNS DUE TO THIS EVENT. THE CUSTOMER'S SECOND, ADJACENT PANTHER WAS UNAFFECTED BY THE INCIDENT AND WAS ASSESSED BY A HOLOGIC FIELD SERVICE ENGINEER AND CLEARED FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22821647 ↗
• InjuryJul 11, 2025Device Fell; Device Fell

  ON JUNE 16, 2025, A CUSTOMER REPORTED TO HOLOGIC THAT THE PANTHER INSTRUMENT SAMPLE BAY CANOPY WAS LOOSE. DURING USER MAINTENANCE, THE SAMPLE CANOPY DOOR DID NOT STAY UP AND FELL DOWN AND HIT THE CUSTOMER IN THE FACE, KNOCKING HER GLASSES TO THE FLOOR. THE CUSTOMER CONFIRMED SHE WAS FINE AND REFUSED MEDICAL ATTENTION. HOLOGIC HAS NOT BEEN INFORMED OF ANY TREATMENT OR ANY ADVERSE OUTCOMES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22484996 ↗
• InjuryJun 20, 2025Power Conditioning Problem; Power Conditioning Problem

  ON MAY 26TH, 2025, A HOLOGIC FIELD SERVICE ENGINEER (FSE) REPORTED TO HOLOGIC THAT A CUSTOMER WAS EXPERIENCING REPEATED ELECTRIC SHOCKS WHILE USING THEIR PANTHER PLUS INSTRUMENT SERIAL NUMBER (B)(6). CUSTOMER NOTED THAT THE ISSUE MAINLY OCCURRED DURING MONTHLY MAINTENANCE AND WHILE LOADING SAMPLES. FSE NOTED THAT THE ELECTRIC SHOCK FELT LIKE STATIC DISCHARGE WITH NO PAIN EXPERIENCED. CUSTOMER DID NOT REPORT ANY INJURIES FROM THE ELECTRIC SHOCKS AND DID NOT SEEK ANY MEDICAL TREATMENT. CUSTOMER WAS INSTRUCTED TO DISCONTINUE USE OF THE INSTRUMENT UNTIL THE ISSUE WAS RESOLVED, SO THE INSTRUMENT WAS POWERED DOWN, DISCONNECTED FROM THE POWER SUPPLY, AND COVERED TO PREVENT USE. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302284 ↗
• InjuryMar 12, 2025Human-Device Interface Problem; Human-Device Interface Problem

  ON FEBRUARY 13TH, 2025, A HOLOGIC MOLECULAR APPLICATION SPECIALIST (MAS) REPORTED TO HOLOGIC THAT A CUSTOMER OPERATOR GOT INJURED WHILST REPLACING THE PERISTALTIC TUBING ON PANTHER INSTRUMENT SERIAL NUMBER (B)(6). WHILE THE MAS INSTRUCTED THE CUSTOMER TO CHANGE THE PERISTALTIC TUBING, THE CUSTOMER ACCIDENTALLY DROPPED THE CLAMP INSIDE OF THE INSTRUMENT AND THE INSTRUMENT¿S MID-BAY DRAWER HAD TO BE OPENED TO RETRIEVE THE PART. WHEN CLOSING THE DRAWER, THE CUSTOMER¿S HAND WAS ACCIDENTALLY PINCHED. THE CUSTOMER¿S HAND WAS EXAMINED BY THE LAB¿S MEDICAL STAFF AND A COOLING PACK WAS APPLIED. THE CUSTOMER DISCONTINUED WORK FOR THE REMAINDER OF THE DAY. CUSTOMER RETURNED TO WORK THE NEXT DAY AND NOTED FEELING BETTER. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADDITIONAL ADVERSE CUSTOMER OUTCOMES RELATED TO THIS SITUATION.

  Patient problems: Bruise/Contusion

  MAUDE report 21586663 ↗
• InjuryOct 11, 2022False Positive Result; False Positive Result

  ON (B)(6) 2022, CUSTOMER CONTACTED HOLOGIC REGARDING AN INCREASED POSITIVE RATE AND DISCREPANT RESULTS PRODUCED BY THE FUSION SARS-COV-2, FUSION ADV/HMPV/RV (AMR), FUSION PARAFLU, AND FUSION FLU A/B/RSV ASSAYS INITIALLY RAN ON PANTHER SN 03517. THE CUSTOMER RETESTED SAMPLES ON A DIFFERENT PLATFORM FOR SARS-COV-2 AND ON THE PANTHER FUSION FOR FUSION FLU, AMR, AND PARAFLU WHICH PRODUCED SEVERAL DISCREPANT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15581997 ↗
• InjuryOct 4, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DURING HOLOGIC SERVICE VISIT TO SITE ON (B)(6) 2022, CUSTOMER INFORMED HOLOGIC OF AN INJURY EVENT THAT HAPPENED ON (B)(6) 2022. HOLOGIC WAS NOT AWARE OF THE INCIDENT PRIOR TO SERVICE VISIT AS CUSTOMER DID NOT REPORT INJURY TO HOLOGIC. CUSTOMER RELAYED THAT DURING THE EMPTYING OF LIQUID WASTE OF PANTHER (SN (B)(4) INTO THE LABORATORY SINK, AN OPERATOR (FEMALE) RECEIVED A DROPLET/SPLASH OF LIQUID WASTE INTO HER LEFT EYE. OPERATOR IMMEDIATELY RINSED AFFECTED EYE WITH STERILE SALINE WATER EYE FLUSH SOLUTION AND CONTACTED A PHYSICIAN WITHIN 24 HOURS. MEDICAL DOCTOR DECIDED TO COMMENCE TREATMENT OF INJURY WITH ANTIBIOTICS, CORTISONE AND ANTI-INFLAMMATORY MEDICATION. HOLOGIC WAS INFORMED THAT AFFECTED OPERATOR IS STILL RECEIVING TREATMENT AT TIME OF EVENT REPORTING (B)(6) 2022). CUSTOMER ALSO STATED OPERATOR HAD VISITED PHYSICIAN 4 TIMES SINCE TIME OF INCIDENT. PHOTOGRAPHIC EVIDENCE OF THE INJURY WAS PROVIDED TO HOLOGIC ON WHICH A RED AREA NEXT TO THE PUPIL OF THE LEFT EYE IS OBSERVABLE. CUSTOMER IS RUNNING HBV, HCV AND HIV ASSAY ON PANTHER SYSTEM (B)(4).

  Patient problems: Eye Injury

  MAUDE report 15536163 ↗
• InjuryOct 12, 2021False Positive Result; False Positive Result

  SUPPLEMENTAL REPORT (SEE SECTION H11 FOR ADDITIONAL CORRECTIONS): FDA REQUESTED FOR HOLOGIC TO PROVIDE A SUPPLEMENTARY REPORT WITH THE CORRECTED PROCODE INFORMATION FOR MDR # 2024800-2021-00010. ORIGINAL REPORT WAS CODED AGAINST PROCODE LSL. THE MDR REPORTED WAS DUE TO FALSE RESULTS DUE TO HIGH CONCENTRATION OF RHINOVIRUS (RV) SAMPLES THAT ARE AFFECTING THE OTHER FUSION RESPIRATORY ANALYTES IN THE PANTHER FUSION ADV/HMPV/RV (AMR) ASSAY. BECAUSE THIS MDR RELATES TO A RESPIRATORY VIRAL PANEL MULTIPLEX NUCLEIC ACID ASSAY, THE PROCODE SHOULD BE UPDATED TO OCC.

  Patient problems: Viral Infection

  MAUDE report 12617312 ↗
• MalfunctionOct 11, 2021Imprecise or Erratic Results; False Positive Result; Contamination /Decontamination Problem; Imprecise or Erratic Results

  SUPPLEMENTAL REPORT: FDA REQUESTED FOR HOLOGIC TO PROVIDE A SUPPLEMENTARY REPORT WITH THE CORRECTED PROCODE INFORMATION FOR MDR # 2024800-2021-00009. ORIGINAL REPORT WAS CODED AGAINST PROCODE LSL, WHICH IS USED FOR DNA REAGENTS, NEISSERIA. THE MDR REPORTED RELATES TO NUCLEIC ACID-BASED IN VITRO DIAGNOSTIC DEVICES FOR THE DETECTION OF 2019-NOVEL CORONAVIRUS (2019-NCOV) AND/OR DIAGNOSIS OF 2019-NCOV INFECTION IN HUMAN CLINICAL SPECIMENS, THE PROCODE SHOULD BE UPDATED TO QJR.

  Patient problems: Insufficient Information; Viral Infection

  MAUDE report 12610333 ↗
• InjurySep 2, 2020Installation-Related Problem; Output Problem; Installation-Related Problem; Output Problem

  THE CUSTOMER SITE NOTIFIED HOLOGIC THAT THERE WERE THREE FAILED SARS-COV-2 RUNS DUE TO INVALID POSITIVE CONTROLS. A REVIEW OF THAT DATA SHOWED LOWER THAN EXPECTED RELATIVE LIGHT UNITS (RLUS) FOR THE SARS-COV-2 CONTROL. ADDITIONAL REVIEW OF APTIMA COMBO 2 (AC2) RESULTS ALSO IDENTIFIED LOWER RLUS, BUT WITHIN ALLOWABLE RANGES. THE CUSTOMER EXPERIENCED THESE ISSUES AFTER THE INSTRUMENT WAS SERVICED ON 07-JUL-2020. ON 06-AUG-2020, HOLOGIC TECHNICAL SERVICE ENGINEERS DETERMINED THAT DURING THE SERVICE VISIT ON 07-JUL-2020, THE CUSTOMER INSTRUMENT HAD BEEN INSTALLED WITH AN AMPLIFICATION INCUBATOR IN PLACE OF ITS TRANSITION INCUBATOR. ON 07-AUG-2020, THE CORRECT TRANSITION INCUBATOR WAS INSTALLED ON THE PANTHER SYSTEM. AFTER COMPLETING ADDITIONAL PERFORMANCE QUALIFICATION TESTING WHICH DEMONSTRATED ACCEPTABLE RLU VALUES, ON 07-AUG-2020, HOLOGIC CLEARED THE PANTHER INSTRUMENT FOR USE. THE HOLOGIC FIELD APPLICATION SPECIALIST (FAS) AND CUSTOMER CHECKED ALL THE RESULTS FROM THE FIRST SUSPECTED PROBLEMS STARTING (B)(6) 2020 UNTIL THE PROBLEM WAS RESOLVED ON 07-AUG-2020. FOR THE SARS-COV-2 RESULTS, THERE WERE 5 QUESTIONABLE SAMPLE RESULTS. THE CUSTOMER TOOK RESPONSIBILITY TO CALL BACK THE RESP

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Test Result

  MAUDE report 10483651 ↗
• InjuryNov 14, 2018Output Problem; Output Problem

  CUSTOMER, (B)(6) HOSPITAL, CONTACTED HOLOGIC ON (B)(6) 2018 TO REPORT THAT THEY HAD A CAP PIERCE FAILURE (CPF) FLAG DUE TO SAMPLE PIPETTOR ERROR WHICH INVALIDATED AN APTIMA COMBO 2 (AC2) RUN (B)(4). THE CUSTOMER ACKNOWLEDGED THAT THE OPERATOR WAS NEW AND DID NOT INSTALL THE SAMPLE SHIELD PROPERLY. AFTER THE CUSTOMER CORRECTLY REINSTALLED THE SAMPLE SHIELD, THE INSTRUMENT PROCESSED WITHOUT ANY ERRORS. PATIENT RESULTS FOR THE INITIAL RUN WERE NOT IMPACTED BECAUSE THE RUN WAS INVALIDATED. ON (B)(6) 2018, THE CUSTOMER CONTACTED HOLOGIC AGAIN (B)(4) TO REPORT AN INCREASED NUMBER OF CT AND GC POSITIVE RESULTS ON AN AC2 RUN, WHICH WAS RELATED TO THE SAMPLE SHIELD NOT SEATED PROPERLY. THE OPERATOR WHO INSTALLED THE SAMPLE SHIELD FOR THIS RUN WAS THE SAME OPERATOR WHO INSTALLED THE SAMPLE SHIELD ON (B)(6) 2018. RUN. HOLOGIC RECOMMENDED THE CUSTOMER TO CHANGE THE SAMPLE SHIELD AND RERUN THE ASSAYS. SINCE THERE WAS A HIGH PREVALENCE OF POSITIVE RESULTS FOR THE AC2 ASSAYS, THE INITIAL RUN RESULTS WERE SUSPECT. THE CUSTOMER HAS STATED THAT THIS OPERATOR WILL UNDERGO ADDITIONAL TRAINING AND HAS ALSO IMPLEMENTED A CHARGE PERSON WHO WILL BE REVIEWING RESULTS IN THE FUTURE. PER RISK ASSESSMENT, IF

  Patient problems: Test Result

  MAUDE report 8071864 ↗
• MalfunctionOct 5, 2018Incorrect, Inadequate or Imprecise Result or Readings; Improper or Incorrect Procedure or Method; Output Problem

  SEE SECTION 10 FOR INVESTIGATION RESULTS.

  Patient problems: Patch Test, Abnormal Results Of; Test Result

  MAUDE report 7940694 ↗
• InjuryOct 1, 2018High Readings; Output Problem; High Readings; Output Problem

  ON (B)(6) 2018, CUSTOMER, (B)(6), AT (B)(6) CONTACTED TECHNICAL SUPPORT (TS) REGARDING AN INCREASE IN NUMBER OF (B)(6) RESULTS. RESULTS FROM THESE ASSAYS WERE REPORTED TO PHYSICIANS BETWEEN (B)(6) 2018. HOLOGIC PRODUCT APPLICATION SPECIALIST (PAS) REVIEWED THE LOGS AND CONFIRMED THE INCREASE IN (B)(6) RESULTS. THE CUSTOMER ACKNOWLEDGED THAT THEY INCORRECTLY INSTALLED SAMPLE SHIELD WHICH LED TO THE CONTAMINATION SEEN IN THE RESULTS. PAS NOTED THAT THERE WERE SEVERAL (B)(6) ACROSS THREE RUNS. SINCE THERE WAS A HIGH PREVALENCE OF (B)(6) RESULTS FOR BOTH THE (B)(4) ASSAYS IN THE THREE ASSAY RUNS, THE INITIAL RUN RESULTS SHOULD HAVE BEEN CONSIDERED SUSPECT. THE CUSTOMER ACKNOWLEDGED THAT THE RESULTS SHOULD NOT HAVE BEEN RELEASED. PER RISK ASSESSMENT, IF THE PATIENT RECEIVED A (B)(6), THE CDC RECOMMENDED TREATMENT FOR THE PATIENT IS ANTIBIOTICS INCLUDING (BUT NOT LIMITED TO) AZITHROMYCIN OR DOXYCYCLINE FOR (B)(6), CEFTRIAXONE AND AZITHROMYCIN FOR (B)(6), AND METRONIDAZOLE OR TINIDAZOLE FOR (B)(6). IF THE PATIENT IS PREGNANT, THE PHYSICIAN IS EXPECTED TO ENSURE THAT THE APPROPRIATE, SAFE ANTIBIOTIC IS ADMINISTERED TO THE PATIENT BASED ON THE NATURE OF THE INFECTION. THE POTENTIAL IMPACT T

  Patient problems: Test Result

  MAUDE report 7923345 ↗
• InjuryJan 10, 2018Break; Detachment Of Device Component

  THE CUSTOMER, (B)(6), REPORTED THE PANEL OF THEIR PANTHER INSTRUMENT 19" PCAP GLASS TOUCH SCREEN MONITOR DETACHED BECAUSE THE RUBBER BAND THAT IS HOLDING IT IN PLACE SNAPPED BUT THE MONITOR WAS STILL USABLE. HOLOGIC FSE REPLACED THE MONITOR TO RESOLVE ISSUE. HOLOGIC'S RISK ASSESSMENT WAS COMPLETED ON 21DEC2017 AFTER THE MONITOR WAS RETURNED FOR EVALUATION. IT WASN'T UNTIL THE INITIAL INVESTIGATION WAS COMPLETE THAT HOLOGIC IDENTIFIED THAT THIS COULD CAUSE INJURY AND WOULD BE CONSIDERED A REPORTABLE EVENT. THERE ARE TWO ASSOCIATED RISKS THAT HOLOGIC ASSESSED. THE RISK OF INCORRECT RESULTS: PER HOLOGIC'S RISK ASSESSMENT, THERE IS NO IMPACT TO RESULTS AS THE MONITOR IS USED TO DISPLAY THE GRAPHICAL USER INTERFACE AND THE INSTRUMENT CAN CONTINUE TO RUN WITHOUT THE TOUCH PANEL. THE SEVERITY ASSOCIATED WITH INCORRECT RESULTS IS NEGLIGIBLE SINCE THE INSTRUMENT WILL CONTINUE TO FUNCTION AS EXPECTED. THE RISK OF OPERATOR INJURY: PER HOLOGIC'S RISK ASSESSMENT, THE SAFETY IMPACT FOR POSSIBLE MEDICAL INTERVENTION CAUSED BY THE FALLING GLASS PANEL WOULD HAVE A SERIOUS SEVERITY RATING. ACCORDING TO THE SUPPLIER, THE GLASS PANEL IS MADE OF SHATTER RESISTANT GLASS AND HAS SMOOTH ROUNDED EDGES, THE

  Patient problems: Injury

  MAUDE report 7178250 ↗
• InjuryJan 10, 2018Detachment Of Device Component; Component Falling; Operating System Becomes Nonfunctional

  THE CUSTOMER, (B)(6), REPORTED THE PANEL OF THEIR PANTHER INSTRUMENT 19" PCAP GLASS MONITOR DETACHED FROM THE BASE OF THE TOUCH SCREEN MONITOR AND FELL TO THE FLOOR. HOWEVER, THE GLASS PANEL DID NOT BREAK. THE GLASS PANEL TOOK THE DIGITIZER WITH IT AS IT BROKE OFF FROM THE RIBBON CABLE AND THUS BECAME UNRESPONSIVE TO TOUCH INPUT. THE CUSTOMER WAS ABLE TO USE THE KEYBOARD TO ENTER INPUT WITHOUT THE TOUCHSCREEN PANEL IN PLACE UNTIL THE MONITOR WAS REPLACED. HOLOGIC'S RISK ASSESSMENT WAS COMPLETED ON 21DEC2017 AFTER THE MONITOR WAS RETURNED FOR EVALUATION. IT WASN'T UNTIL THE INITIAL INVESTIGATION WAS COMPLETE THAT HOLOGIC IDENTIFIED THAT THIS COULD CAUSE INJURY AND WOULD BE CONSIDERED A REPORTABLE EVENT. THERE ARE TWO ASSOCIATED RISKS THAT HOLOGIC ASSESSED. THE RISK OF INCORRECT RESULTS: PER HOLOGIC'S RISK ASSESSMENT, THERE IS NO IMPACT TO RESULTS AS THE MONITOR IS USED TO DISPLAY THE GRAPHICAL USER INTERFACE AND THE INSTRUMENT CAN CONTINUE TO RUN WITHOUT THE TOUCH PANEL. THE SEVERITY ASSOCIATED WITH INCORRECT RESULTS IS NEGLIGIBLE SINCE THE INSTRUMENT WILL CONTINUE TO FUNCTION AS EXPECTED. THE RISK OF OPERATOR INJURY: PER HOLOGIC'S RISK ASSESSMENT, THE SAFETY IMPACT FOR POSSIBLE MED

  Patient problems: No Code Available

  MAUDE report 7178183 ↗
• InjuryNov 29, 2017Improper or Incorrect Procedure or Method

  (B)(6) (CUSTOMER) REPORTED THAT ONE OF THEIR OPERATORS ((B)(6)) HAD SPLASHED BLEACH INTO ONE OF HER EYES ON. IT HAPPENED WHEN THE OPERATOR WAS MAKING BLEACH SOLUTION TO CLEAN PANTHER WORK SURFACE AREAS. THE OPERATOR WAS NOT WEARING ANY EYE PROTECTIVE GLASSES OR GOGGLES. THE OPERATOR WASHED HER EYE WITH WATER AND THEN WENT TO SEEK MEDICAL ATTENTION. THE BLEACH HAD BURNED THE OUTER LAYER OF HER AFFECTED EYE AND HER VISION HAS BEEN BLURRY. THE DOCTOR HAS INSTRUCTED THE OPERATOR TO WEAR GOGGLES UNTIL THE EYE HAS HEALED AND WAS GIVEN MEDICAL LEAVE.

  Patient problems: Blurred Vision; Burn(s)

  MAUDE report 7067728 ↗