ORTHO 6904577 (REF 6904576)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10758750012824), received between Nov 15, 2022 and Jun 12, 2023 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (14 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MXP32210136 RA602179 ON (B)(6) 2023, A CUSTOMER CONTACTED ORTHO CARE TO REPORT WHAT WAS DESCRIBED AS DISCREPANT REACTIONS IN ABO TYPING FOR TWO PATIENT SAMPLES USING ORTHO BIOVUE SYSTEM ABO-RH REVERSE CASSETTE LOT ABR385J IN CONJUNCTION WITH THEIR ORTHO VISION MAX BIOVUE ANALYZER #J80002366 EQUIPPED WITH SOFTWARE VERSION 5.13.4. REAGENT: ORTHO BIOVUE SYSTEM ABO-RH REVERSE CASSETTE (PRODUCT CODE 707100; LOT ABR385J; EXPIRY 21 AUGUST 2023; MANUFACTURED 24 NOVEMBER 2022) SAMPLE INFORMATION PATIENT 1 SAMPLE ID (B)(6) KNOWN TO BE B(ABO2) BLOOD GROUP. PATIENT 2 SAMPLE ID (B)(6) KNOWN TO BE AB(ABO3) BLOOD GROUP. THE CUSTOMER REPORTED THAT, ON (B)(6) 2023, THEY HAD TESTED SAMPLES FROM PATIENT 1 AND PATIENT 2 FOR ABO FORWARD AND REVERSE TYPING USING ORTHO BIOVUE SYSTEM ABO-RH REVERSE CASSETTE LOT ABR385J IN CONJUNCTION WITH THEIR ORTHO VISION MAX BIOVUE ANALYZER, AND THAT THEY HAD OBTAINED THE FOLLOWING RESULTS: PATIENT 1: AB(ABO3) POSITIVE PATIENT 2: B(ABO2) POSITIVE THE CUSTOMER STATED THAT PATIENT 1 HAD INFORMED THEM THAT BLOOD GROUP AB(ABO3) WAS INCORRECT, AND THEY ARE BLOOD GROUP B(ABO2). THE CUSTOMER REPORTED THAT, ON THE SAME DAY, THEY HAD REPEATED TESTING FOR BOTH PATIENT SAMPLES FO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17105926 ↗
• MalfunctionMar 21, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MXP2506670 WINDCHILL RA601377 PROBLEM STATEMENT AND DESCRIPTION: CUSTOMER REPORTING CIMS35 UNEXPECTED [ CARD / CASSETTE ] AT PROCESS END APSW68 [ CARD / CASSETTE ] NOT ROTATED DURING PROCESSING ADDITIONAL DETAILS (INCLUDE START DATE, FREQUENCY, OBSERVATIONS, SAMPLE ID/REAGENTS ETC. AS NEEDED): 2/27/2023 TROUBLESHOOTING STEPS REQUESTED BY TSC: - TSS INSTRUCTED CUSTOMER TO SHUT DOWN, CLEAN IMAGING SYSTEM, AND REBOOT. TSS WILL FOLLOW UP TO REVIEW IMAGES FROM AROUND THE TIME OF THE ERROR FOR POTENTIAL CIMS MISMATCH. NEXT ACTION FOR CONTACT: REBOOT ORTHO HAS INVESTIGATED UNDER RCI 509093. THE CIMS CAMERA SOFTWARE DRIVER PROVIDED BY A 3RD PARTY, CONTAINS A FIRST-IN-FIRST-OUT IMAGE QUEUE WHICH IS UTILIZED DURING CAMERA CAPTURE EVENTS. AS NEW IMAGES ARE CAPTURED, THEY ARE PLACED AT THE BACK OF THE QUEUE WHILE CIMS CONTROL SOFTWARE WILL RETRIEVE IMAGES FROM THE FRONT OF THE QUEUE. THE IMAGE QUEUE ALLOWS FOR SEVERAL IMAGES TO BE CAPTURED AND RETRIEVED AS NEEDED. COMMUNICATION ISSUES BETWEEN CIMS CONTROL SOFTWARE AND THE CAMERA HARDWARE MAY CAUSE THE COUNT OF EXPECTED IMAGES IN THE CAMERA QUEUE TO BE GREATER THAN THE COUNT EXPECTED BY CIMS CONTROL SOFTWARE. WHEN THIS OCCURS, THE IMAGES SENT F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16581882 ↗
• MalfunctionFeb 16, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MXP2468775 WINDCHILL RA6001111. CUSTOMER CALLED TO REPORT CIMS35 ERROR CODES. THE COMPLAINT REVIEW WAS UNABLE TO CONFIRM IF AN IMAGE MISMATCH OCCURRED AS THE RECORD IS AGED AND NO LOG FILES ARE ABLE TO BE RETRIEVED FOR REVIEW. NO ERRONEOUS RESULTS WERE REPORTED. ORTHO IS CONSERVATIVELY UPDATING THIS TO A PHS FOR CHU TO PERFORM AN ASSESSMENT FOR DETERMINATION OF A REPORTABLE EVENT. ORTHO HAS INVESTIGATED UNDER RCI (B)(4). THE CIMS CAMERA SOFTWARE DRIVER PROVIDED BY A 3RD PARTY, CONTAINS A FIRST-IN-FIRST-OUT IMAGE QUEUE WHICH IS UTILIZED DURING CAMERA CAPTURE EVENTS. AS NEW IMAGES ARE CAPTURED, THEY ARE PLACED AT THE BACK OF THE QUEUE WHILE CIMS CONTROL SOFTWARE WILL RETRIEVE IMAGES FROM THE FRONT OF THE QUEUE. THE IMAGE QUEUE ALLOWS FOR SEVERAL IMAGES TO BE CAPTURED AND RETRIEVED AS NEEDED. COMMUNICATION ISSUES BETWEEN CIMS CONTROL SOFTWARE AND THE CAMERA HARDWARE MAY CAUSE THE COUNT OF EXPECTED IMAGES IN THE CAMERA QUEUE TO BE GREATER THAN THE COUNT EXPECTED BY CIMS CONTROL SOFTWARE. WHEN THIS OCCURS, THE IMAGES SENT FROM THE CAMERA TO CIMS SOFTWARE LOSE THE 1:1 SEQUENCING WITH THE PHYSICAL CONSUMABLE IN THE CAMERA UNIT AT THE TIME AN IMAGE IS SENT. SOFTWARE EXCEPTIONS REGULARLY OC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16390115 ↗
• MalfunctionFeb 13, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MXP 2496228 RA600972 CUSTOMER CALLED TO REPORT CIMS02 AND CIMS35 ERROR CODES. CUSTOMER NEEDED TO REBOOT ANALYZER. NO ERRONEOUS RESULTS WERE REPORTED. ORTHO IS CONSERVATIVELY UPDATING THIS TO A PHS FOR CHU TO PERFORM AN ASSESSMENT FOR DETERMINATION OF A REPORTABLE EVENT. ORTHO HAS INVESTIGATED UNDER RCI 509093. THE CIMS CAMERA SOFTWARE DRIVER PROVIDED BY A 3RD PARTY, CONTAINS A FIRST-IN-FIRST-OUT IMAGE QUEUE WHICH IS UTILIZED DURING CAMERA CAPTURE EVENTS. AS NEW IMAGES ARE CAPTURED, THEY ARE PLACED AT THE BACK OF THE QUEUE WHILE CIMS CONTROL SOFTWARE WILL RETRIEVE IMAGES FROM THE FRONT OF THE QUEUE. THE IMAGE QUEUE ALLOWS FOR SEVERAL IMAGES TO BE CAPTURED AND RETRIEVED AS NEEDED. COMMUNICATION ISSUES BETWEEN CIMS CONTROL SOFTWARE AND THE CAMERA HARDWARE MAY CAUSE THE COUNT OF EXPECTED IMAGES IN THE CAMERA QUEUE TO BE GREATER THAN THE COUNT EXPECTED BY CIMS CONTROL SOFTWARE. WHEN THIS OCCURS, THE IMAGES SENT FROM THE CAMERA TO CIMS SOFTWARE LOSE THE 1:1 SEQUENCING WITH THE PHYSICAL CONSUMABLE IN THE CAMERA UNIT AT THE TIME AN IMAGE IS SENT. SOFTWARE EXCEPTIONS REGULARLY OCCUR IN THE CIMS CONTROL SOFTWARE AND WITHIN THE CAMERA SOFTWARE DRIVER. THE EXISTING SOFTWARE IS DESIGNED TO RECO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16367466 ↗
• MalfunctionFeb 13, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MXP 2496225 (B)(4) CUSTOMER CALLED TO REPORT CIMS02 AND CIMS35 ERROR CODES. CUSTOMER NEEDED TO REBOOT ANALYZER. NO ERRONEOUS RESULTS WERE REPORTED. ORTHO IS CONSERVATIVELY UPDATING THIS TO A PHS FOR CHU TO PERFORM AN ASSESSMENT FOR DETERMINATION OF A REPORTABLE EVENT. ORTHO HAS INVESTIGATED UNDER RCI (B)(4). THE CIMS CAMERA SOFTWARE DRIVER PROVIDED BY A 3RD PARTY, CONTAINS A FIRST-IN-FIRST-OUT IMAGE QUEUE WHICH IS UTILIZED DURING CAMERA CAPTURE EVENTS. AS NEW IMAGES ARE CAPTURED, THEY ARE PLACED AT THE BACK OF THE QUEUE WHILE CIMS CONTROL SOFTWARE WILL RETRIEVE IMAGES FROM THE FRONT OF THE QUEUE. THE IMAGE QUEUE ALLOWS FOR SEVERAL IMAGES TO BE CAPTURED AND RETRIEVED AS NEEDED. COMMUNICATION ISSUES BETWEEN CIMS CONTROL SOFTWARE AND THE CAMERA HARDWARE MAY CAUSE THE COUNT OF EXPECTED IMAGES IN THE CAMERA QUEUE TO BE GREATER THAN THE COUNT EXPECTED BY CIMS CONTROL SOFTWARE. WHEN THIS OCCURS, THE IMAGES SENT FROM THE CAMERA TO CIMS SOFTWARE LOSE THE 1:1 SEQUENCING WITH THE PHYSICAL CONSUMABLE IN THE CAMERA UNIT AT THE TIME AN IMAGE IS SENT. SOFTWARE EXCEPTIONS REGULARLY OCCUR IN THE CIMS CONTROL SOFTWARE AND WITHIN THE CAMERA SOFTWARE DRIVER. THE EXISTING SOFTWARE IS DESIGNED TO RECOVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16366226 ↗
• MalfunctionJan 24, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  (B)(4); WINDCHILL RA600838 CUSTOMER CALLING TO REPORT CIMS02,28, 35 ERROR CODES. TESTING WAS ABORTED. CUSTOMER REBOOTED ANALYZER. FE WENT TO SITE AND CONFIRMED ISSUE. NO ERRONEOUS RESULTS WERE REPORTED. ORTHO IS CONSERVATIVELY UPDATING THIS TO A PHS FOR CHU TO PERFORM AN ASSESSMENT FOR DETERMINATION OF A REPORTABLE EVENT. ORTHO HAS INVESTIGATED UNDER (B)(4). THE CIMS CAMERA SOFTWARE DRIVER PROVIDED BY A 3RD PARTY, CONTAINS A FIRST-IN-FIRST-OUT IMAGE QUEUE WHICH IS UTILIZED DURING CAMERA CAPTURE EVENTS. AS NEW IMAGES ARE CAPTURED, THEY ARE PLACED AT THE BACK OF THE QUEUE WHILE CIMS CONTROL SOFTWARE WILL RETRIEVE IMAGES FROM THE FRONT OF THE QUEUE. THE IMAGE QUEUE ALLOWS FOR SEVERAL IMAGES TO BE CAPTURED AND RETRIEVED AS NEEDED. COMMUNICATION ISSUES BETWEEN CIMS CONTROL SOFTWARE AND THE CAMERA HARDWARE MAY CAUSE THE COUNT OF EXPECTED IMAGES IN THE CAMERA QUEUE TO BE GREATER THAN THE COUNT EXPECTED BY CIMS CONTROL SOFTWARE. WHEN THIS OCCURS, THE IMAGES SENT FROM THE CAMERA TO CIMS SOFTWARE LOSE THE 1:1 SEQUENCING WITH THE PHYSICAL CONSUMABLE IN THE CAMERA UNIT AT THE TIME AN IMAGE IS SENT. SOFTWARE EXCEPTIONS REGULARLY OCCUR IN THE CIMS CONTROL SOFTWARE AND WITHIN THE CAMERA SOFTWARE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16233693 ↗
• MalfunctionJan 18, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  (B)(4) RA600673 ORTHO HAS INVESTIGATED UNDER RCI 509093. THE CIMS CAMERA SOFTWARE DRIVER PROVIDED BY A 3RD PARTY, CONTAINS A FIRST-IN-FIRST-OUT IMAGE QUEUE WHICH IS UTILIZED DURING CAMERA CAPTURE EVENTS. AS NEW IMAGES ARE CAPTURED, THEY ARE PLACED AT THE BACK OF THE QUEUE WHILE CIMS CONTROL SOFTWARE WILL RETRIEVE IMAGES FROM THE FRONT OF THE QUEUE. THE IMAGE QUEUE ALLOWS FOR SEVERAL IMAGES TO BE CAPTURED AND RETRIEVED AS NEEDED. COMMUNICATION ISSUES BETWEEN CIMS CONTROL SOFTWARE AND THE CAMERA HARDWARE MAY CAUSE THE COUNT OF EXPECTED IMAGES IN THE CAMERA QUEUE TO BE GREATER THAN THE COUNT EXPECTED BY CIMS CONTROL SOFTWARE. WHEN THIS OCCURS, THE IMAGES SENT FROM THE CAMERA TO CIMS SOFTWARE LOSE THE 1:1 SEQUENCING WITH THE PHYSICAL CONSUMABLE IN THE CAMERA UNIT AT THE TIME AN IMAGE IS SENT. SOFTWARE EXCEPTIONS REGULARLY OCCUR IN THE CIMS CONTROL SOFTWARE AND WITHIN THE CAMERA SOFTWARE DRIVER. THE EXISTING SOFTWARE IS DESIGNED TO RECOVER FROM THESE EXCEPTIONS AND RETURN TO NORMAL OPERATION. IN RARE CASES THESE EXCEPTIONS RESULT IN 1-2 IMAGES REMAINING IN THE QUEUE WHICH CAN INITIATE THE CAMERA-QUEUE-TO-CIMS IMAGE MISMATCH. THIS IMAGE RETURN SEQUENCING ERROR PERSISTS UNTIL THE VISION A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16196904 ↗
• MalfunctionJan 13, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  (B)(4) WINDCHILL RA600575 ORTHO HAS INVESTIGATED UNDER (B)(4). THE CIMS CAMERA SOFTWARE DRIVER PROVIDED BY A 3RD PARTY, CONTAINS A FIRST-IN-FIRST-OUT IMAGE QUEUE WHICH IS UTILIZED DURING CAMERA CAPTURE EVENTS. AS NEW IMAGES ARE CAPTURED, THEY ARE PLACED AT THE BACK OF THE QUEUE WHILE CIMS CONTROL SOFTWARE WILL RETRIEVE IMAGES FROM THE FRONT OF THE QUEUE. THE IMAGE QUEUE ALLOWS FOR SEVERAL IMAGES TO BE CAPTURED AND RETRIEVED AS NEEDED. COMMUNICATION ISSUES BETWEEN CIMS CONTROL SOFTWARE AND THE CAMERA HARDWARE MAY CAUSE THE COUNT OF EXPECTED IMAGES IN THE CAMERA QUEUE TO BE GREATER THAN THE COUNT EXPECTED BY CIMS CONTROL SOFTWARE. WHEN THIS OCCURS, THE IMAGES SENT FROM THE CAMERA TO CIMS SOFTWARE LOSE THE 1:1 SEQUENCING WITH THE PHYSICAL CONSUMABLE IN THE CAMERA UNIT AT THE TIME AN IMAGE IS SENT. SOFTWARE EXCEPTIONS REGULARLY OCCUR IN THE CIMS CONTROL SOFTWARE AND WITHIN THE CAMERA SOFTWARE DRIVER. THE EXISTING SOFTWARE IS DESIGNED TO RECOVER FROM THESE EXCEPTIONS AND RETURN TO NORMAL OPERATION. IN RARE CASES THESE EXCEPTIONS RESULT IN 1-2 IMAGES REMAINING IN THE QUEUE WHICH CAN INITIATE THE CAMERA-QUEUE-TO-CIMS IMAGE MISMATCH. THIS IMAGE RETURN SEQUENCING ERROR PERSISTS UNTIL THE VI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16165025 ↗
• MalfunctionJan 13, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  (B)(4) WINDCHILL RA600577 ORTHO HAS INVESTIGATED UNDER RCI 509093. THE CIMS CAMERA SOFTWARE DRIVER PROVIDED BY A 3RD PARTY, CONTAINS A FIRST-IN-FIRST-OUT IMAGE QUEUE WHICH IS UTILIZED DURING CAMERA CAPTURE EVENTS. AS NEW IMAGES ARE CAPTURED, THEY ARE PLACED AT THE BACK OF THE QUEUE WHILE CIMS CONTROL SOFTWARE WILL RETRIEVE IMAGES FROM THE FRONT OF THE QUEUE. THE IMAGE QUEUE ALLOWS FOR SEVERAL IMAGES TO BE CAPTURED AND RETRIEVED AS NEEDED. COMMUNICATION ISSUES BETWEEN CIMS CONTROL SOFTWARE AND THE CAMERA HARDWARE MAY CAUSE THE COUNT OF EXPECTED IMAGES IN THE CAMERA QUEUE TO BE GREATER THAN THE COUNT EXPECTED BY CIMS CONTROL SOFTWARE. WHEN THIS OCCURS, THE IMAGES SENT FROM THE CAMERA TO CIMS SOFTWARE LOSE THE 1:1 SEQUENCING WITH THE PHYSICAL CONSUMABLE IN THE CAMERA UNIT AT THE TIME AN IMAGE IS SENT. SOFTWARE EXCEPTIONS REGULARLY OCCUR IN THE CIMS CONTROL SOFTWARE AND WITHIN THE CAMERA SOFTWARE DRIVER. THE EXISTING SOFTWARE IS DESIGNED TO RECOVER FROM THESE EXCEPTIONS AND RETURN TO NORMAL OPERATION. IN RARE CASES THESE EXCEPTIONS RESULT IN 1-2 IMAGES REMAINING IN THE QUEUE WHICH CAN INITIATE THE CAMERA-QUEUE-TO-CIMS IMAGE MISMATCH. THIS IMAGE RETURN SEQUENCING ERROR PERSISTS UNTIL TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16164810 ↗
• MalfunctionJan 12, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  (B)(4) RA600655 ORTHO HAS INVESTIGATED UNDER (B)(4). THE CIMS CAMERA SOFTWARE DRIVER PROVIDED BY A 3RD PARTY, CONTAINS A FIRST-IN-FIRST-OUT IMAGE QUEUE WHICH IS UTILIZED DURING CAMERA CAPTURE EVENTS. AS NEW IMAGES ARE CAPTURED, THEY ARE PLACED AT THE BACK OF THE QUEUE WHILE CIMS CONTROL SOFTWARE WILL RETRIEVE IMAGES FROM THE FRONT OF THE QUEUE. THE IMAGE QUEUE ALLOWS FOR SEVERAL IMAGES TO BE CAPTURED AND RETRIEVED AS NEEDED. COMMUNICATION ISSUES BETWEEN CIMS CONTROL SOFTWARE AND THE CAMERA HARDWARE MAY CAUSE THE COUNT OF EXPECTED IMAGES IN THE CAMERA QUEUE TO BE GREATER THAN THE COUNT EXPECTED BY CIMS CONTROL SOFTWARE. WHEN THIS OCCURS, THE IMAGES SENT FROM THE CAMERA TO CIMS SOFTWARE LOSE THE 1:1 SEQUENCING WITH THE PHYSICAL CONSUMABLE IN THE CAMERA UNIT AT THE TIME AN IMAGE IS SENT. SOFTWARE EXCEPTIONS REGULARLY OCCUR IN THE CIMS CONTROL SOFTWARE AND WITHIN THE CAMERA SOFTWARE DRIVER. THE EXISTING SOFTWARE IS DESIGNED TO RECOVER FROM THESE EXCEPTIONS AND RETURN TO NORMAL OPERATION. IN RARE CASES THESE EXCEPTIONS RESULT IN 1-2 IMAGES REMAINING IN THE QUEUE WHICH CAN INITIATE THE CAMERA-QUEUE-TO-CIMS IMAGE MISMATCH. THIS IMAGE RETURN SEQUENCING ERROR PERSISTS UNTIL THE VISION ANALY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16148479 ↗
• MalfunctionJan 10, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  (B)(4). A REVIEW OF ALL COMPLAINT RECORDS ASSOCIATED WITH CURRENT ISSUE VISION / VISION MAX - UNEXPECTED BEHAVIOUR OF THE CARD IMAGING SYSTEM (B)(4) INDICATES THAT THIS COMPLAINT SHOULD BE REOPENED AND UPDATED FROM CE TO PHSE. THE COMPLAINT REVIEW WAS UNABLE TO CONFIRM IF AN IMAGE MISMATCH OCCURRED AS THE RECORD IS AGED AND NO LOG FILES ARE ABLE TO BE RETRIEVED FOR REVIEW. ORTHO IS CONSERVATIVELY UPDATING THIS TO A PHS FOR CHU TO PERFORM AN ASSESSMENT FOR DETERMINATION OF A REPORTABLE EVENT. ORTHO HAS INVESTIGATED UNDER RCI 509093. THE CIMS CAMERA SOFTWARE DRIVER PROVIDED BY A 3RD PARTY, CONTAINS A FIRST-IN-FIRST-OUT IMAGE QUEUE WHICH IS UTILIZED DURING CAMERA CAPTURE EVENTS. AS NEW IMAGES ARE CAPTURED, THEY ARE PLACED AT THE BACK OF THE QUEUE WHILE CIMS CONTROL SOFTWARE WILL RETRIEVE IMAGES FROM THE FRONT OF THE QUEUE. THE IMAGE QUEUE ALLOWS FOR SEVERAL IMAGES TO BE CAPTURED AND RETRIEVED AS NEEDED. COMMUNICATION ISSUES BETWEEN CIMS CONTROL SOFTWARE AND THE CAMERA HARDWARE MAY CAUSE THE COUNT OF EXPECTED IMAGES IN THE CAMERA QUEUE TO BE GREATER THAN THE COUNT EXPECTED BY CIMS CONTROL SOFTWARE. WHEN THIS OCCURS, THE IMAGES SENT FROM THE CAMERA TO CIMS SOFTWARE LOSE THE 1:1 SEQUENCI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16132307 ↗
• MalfunctionDec 22, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  (B)(4) WINDCHILL (B)(4) ORTHO HAS INVESTIGATED UNDER (B)(4). THE CIMS CAMERA SOFTWARE DRIVER PROVIDED BY A 3RD PARTY, CONTAINS A FIRST-IN-FIRST-OUT IMAGE QUEUE WHICH IS UTILIZED DURING CAMERA CAPTURE EVENTS. AS NEW IMAGES ARE CAPTURED, THEY ARE PLACED AT THE BACK OF THE QUEUE WHILE CIMS CONTROL SOFTWARE WILL RETRIEVE IMAGES FROM THE FRONT OF THE QUEUE. THE IMAGE QUEUE ALLOWS FOR SEVERAL IMAGES TO BE CAPTURED AND RETRIEVED AS NEEDED. COMMUNICATION ISSUES BETWEEN CIMS CONTROL SOFTWARE AND THE CAMERA HARDWARE MAY CAUSE THE COUNT OF EXPECTED IMAGES IN THE CAMERA QUEUE TO BE GREATER THAN THE COUNT EXPECTED BY CIMS CONTROL SOFTWARE. WHEN THIS OCCURS, THE IMAGES SENT FROM THE CAMERA TO CIMS SOFTWARE LOSE THE 1:1 SEQUENCING WITH THE PHYSICAL CONSUMABLE IN THE CAMERA UNIT AT THE TIME AN IMAGE IS SENT. SOFTWARE EXCEPTIONS REGULARLY OCCUR IN THE CIMS CONTROL SOFTWARE AND WITHIN THE CAMERA SOFTWARE DRIVER. THE EXISTING SOFTWARE IS DESIGNED TO RECOVER FROM THESE EXCEPTIONS AND RETURN TO NORMAL OPERATION. IN RARE CASES THESE EXCEPTIONS RESULT IN 1-2 IMAGES REMAINING IN THE QUEUE WHICH CAN INITIATE THE CAMERA-QUEUE-TO-CIMS IMAGE MISMATCH. THIS IMAGE RETURN SEQUENCING ERROR PERSISTS UNTIL THE VISI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16035721 ↗
• MalfunctionDec 20, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MXP 32193161; RA600443 ORTHO CLINICAL DIAGNOSTICS RECEIVED COMPLAINTS IN WHICH CUSTOMERS OBTAINED UNEXPECTED RESULTS ON THEIR ORTHO VISION ANALYZER. UPON FURTHER INVESTIGATION, ORTHO INVESTIGATION CONFIRMED THAT INCORRECT UTILIZATION OF THE ¿ASSIGN TO POSITION¿ FEATURE BY PHYSICALLY PLACING THE SAMPLE(S) IN A DIFFERENT LOCATION THAN WAS MANUALLY ASSIGNED WHICH CAUSED THE MIS IDENTIFICATION OF A SAMPLE. ONCE AN IDENTIFIED SAMPLE HAS BEEN MANUALLY ASSIGNED TO A LOCATION ON THE ANALYZER SRDR (SAMPLE REAGENT DILUTION ROTOR), THIS IDENTIFIER IS BOUND TO THE ASSIGNED POSITION. ALTHOUGH THE SRDR CAMERA DOES ATTEMPT TO READ THE SAMPLE AGAIN: 1. IF A BARCODE IS NOT PRESENT OR UNABLE TO BE READ, NO BARCODE IS READ. 2. IF A DIFFERENT OR WRONG BARCODE HAPPENS TO BE PRESENT THAT DOES NOT MATCH THE MANUALLY ASSIGNED SAMPLE ID IN THAT SPOT, THE VISION SOFTWARE READS IT BUT IGNORES THE READING MADE BY THE LASER SCANNER AND USES THE BARCODE MANUALLY ASSIGNED. THE FOLLOWING SCENARIOS APPLY: A. PHYSICALLY PLACING THE PROGRAMMED SAMPLE INTO A DIFFERENT LOCATION ON THE ANALYZER THAN THE POSITION THAT WAS PROGRAMMED AND INTENDED BY THE USER B. PHYSICALLY PLACING A SAMPLE OTHER THAN THE INTENDED SAMPLE I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16016679 ↗
• MalfunctionDec 19, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  RESULTS ON THE ORTHO VISION MAX ID-MTS ANALYSER SOFTWARE APPEAR IN AN ABNORMAL COLOUR SCHEME WITH CONDITION CODE FLAGS IN MULTIPLE COLUMNS. THE MOST PROBABLE ASSIGNABLE CAUSE IS ANALYSER RELATED, WHEN AN ERROR OCCURS BETWEEN THE CAMERA AND/OR CAMERA SOFTWARE AND CIMS, THE IMAGE QUEUES CAN CONTAIN 1-2 IMAGES MORE THAN THE COUNT EXPECTED BY CIMS SOFTWARE. IF IMAGES REMAIN IN THE QUEUES FROM A PREVIOUS OPERATION, THEY WILL BE USED FIRST, INSTEAD OF THE INTENDED/APPROPRIATE IMAGE. THE RESULT WAS REJECTED BY THE ANALYSER. NO BIASED RESULT WAS REPORTED TO PHYSICIAN. NO PATIENT WAS HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16004117 ↗
• MalfunctionNov 15, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS REPORT CORRESPONDS TO COMPLAINT #(B)(4) AND (B)(4) CUSTOMER CONTACTED ORTHOCARE TECHNICAL SUPPORT TO REPORT DISCREPANT RESULTS OF ONE SAMPLE FOR RHD TYPING. CUSTOMER WAS EXPECTING A NEGATIVE REACTION FOR ONE SAMPLE, AS PATIENT IS D NEGATIVE, BUT A POSITIVE REACTION WAS OBTAINED. SECOND SAMPLE HAD NO HISTORICAL RESULT, SO WAS NOT REPORTED AS DISCREPANT. PATIENT INFORMATION: SAMPLE A ID: 10047957439 (15-88-59-36-91-FF-6C-02-A4-16-CA-B1-1A-80-BA-2C-9C-B4-2F-20-35-E5-CF-2E-E8-46-75-70-71-58-A1-59) KNOWN AS RH-D NEGATIVE, RESULTED AS RHD POSITIVE. SAMPLE B ID: 10047958716 (07-7F-C6-88-86-D2-02-AA-E9-CE-CA-32-A7-27-93-53-B4-BE-A6-3B-24-3A-19-62-E4-A0-20-9B-17-FF-00-2F) NO PATIENT HISTORY, RESULTED AS RHD NEGATIVE. REPEATING THE TEST ON THE ANALYZER GAVE A NEGATIVE REACTION FOR SAMPLE A. ADDITIONAL DETAILS (INCLUDE START DATE, FREQUENCY, OBSERVATIONS, SAMPLE ID/REAGENTS ETC. AS NEEDED): REPORTED ON 19-OCT-2022 ACTIONS ALREADY PERFORMED BY CONTACT: REPEATED TESTING TROUBLESHOOTING STEPS REQUESTED BY TSC: TSC WILL FOLLOW UP WITH SITE FOR DETAILS ON THE ISSUE. REQUESTING COPIES OF ORDER REPORT FOR INVESTIGATION NEXT ACTION FOR CONTACT: WAITING FOR INFORMATION AS PER ORDER REPORT: SAMPLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15800919 ↗