STA COMPACT MAX
Report
- Report Number
- 2245451-2023-00001
- Event Type
- Death
- Date Received
- November 13, 2023
- Date of Event
- October 16, 2023
- Report Date
- January 12, 2024
- Manufacturer
- DIAGNOSTICA STAGO S.A.S
- Product Code
- JPA
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
IMMEDIATE ACTIONS: ON (B)(6), THE CUSTOMER STATED THAT THEY WOULD STOP RUNNING ANTI XA TESTS ON THE INSTRUMENT. ON (B)(6), AN AUTOMATIC RERUN RULE WAS SET UP IN THE STA COAG EXPERT (STAGO MIDDLEWARE) FOR ANTI XA RESULTS <0.10 IU/ML. INVESTIGATIONS: OUR TECHNICAL TEAM PERFORMED A THOROUGH REVIEW OF THE INSTRUMENT LOG FILES WHICH WERE COLLECTED ON SEVERAL OCCASIONS. ALL QC WERE WITHIN STAGO RANGES AND THERE WAS NO ERROR MESSAGES FOUND ON THE ERROR LOG FILE. THE ANALYSIS OF THE SAMPLE PIPETTING HEIGHTS CONFIRMS THAT THERE WAS A BAD PIPETTING OF THE SAMPLE WHICH IS CONSISTENT WITH ANTI-XA RESULT <0.1. AS A PRECAUTIONARY MEASURE, THE REPLACEMENT OF THE LLD CABLE AND THE NEEDLE#1 ON SN (B)(6) WAS RECOMMENDED. IN ADDITION, THE ANALYSIS OF THE LOG FILES SHOWED THAT OTHER SAMPLE IDS (SIDS) MAY HAVE EXPERIENCED ERRONEOUS SAMPLE PIPETTING FOR ANTI XA TESTS AND FIBRINOGEN TESTS (TO A LESSER EXTENT). A FURTHER ANALYSIS OF THE LOG FILE HISTORY ALLOWED US TO GO BACK TO (B)(6) 2023 AND CONFIRM THAT THE PROBLEMS OF ANTI XA TOO LOW RESULTS APPEARED RANDOMLY FROM (B)(6) 2023. THE CUSTOMER WAS PROVIDED THE LIST OF POTENTIALLY ERRONEOUS SAMPLE PIPETTING SIDS. THE ROOT CAUSE OF THIS SAMPLE PIPETTING ISSUE IS STILL UNDETERMINED. REGARDING THE CLINICAL IMPACT OF THE SPECIFIC CASE THAT TRIGGERED THIS MDR REPORT, THERE IS NO KNOWN LINKAGE BETWEEN THE ERRONEOUS RESULT OF SID (B)(6) ANTI XA <0.10 IU/ML RELEASED ON (B)(6) AT 3:00 A.M. AND THE PATIENT'S CLINICAL STATUS (BLOODY STOOLS) OR THE THERAPEUTIC TREATMENT (NO CHANGE IN THE PATIENT'S TREATMENT). FURTHERMORE, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION INDICATING THAT THE PATIENT'S DEATH WAS IN ANY WAY ATTRIBUTED TO THE STAGO DEVICE. THE PATIENT WAS DESCRIBED AS AN EXTENDED CARE MALE PATIENT WITH PRE-EXISTING CONDITIONS, BUT NO INFORMATION ABOUT THESE CONDITIONS WAS SHARED. ACTIONS CARRIED OUT: (B)(6): REPLACEMENT OF LLD CABLE AND NEEDLE #1. (B)(6): MAPPING OF THE DRAWER AND SET UP OF LIQUID LEVEL DETECTION FEATURES. (B)(6): SCHEDULED PREVENTIVE MAINTENANCE PERFORMED. UPCOMING ACTIONS: - MONITORING OF THE SYSTEM. NEW LOG FILES ARE TO BE RETRIEVED BY THE END OF (B)(6)2023. - CONTINUING INTERNAL INVESTIGATIONS. RELATED REPORT: 8043723-2023-00008 STAGO REFERENCE FILE: (B)(4).
THE FOLLOWING ACTIONS WERE CARRIED OUT ON THE INSTRUMENT BY OUR FIELD SERVICE TEAM: 06NOV2023: REPLACEMENT OF LLD CABLE AND NEEDLE #1. 10NOV2023: MAPPING OF THE DRAWER AND SET UP OF LIQUID LEVEL DETECTION FEATURES. 26NOV2023: SCHEDULED PREVENTIVE MAINTENANCE PERFORMED. AFTER A MONITORING PERIOD FOLLOWING THE ABOVE ACTIONS, NEW INSTRUMENT LOG FILES WERE COLLECTED ON THE 3RD JANUARY 2024 AND WERE ANALYZED BY OUR STAGO SUPPORT TEAM IN FRANCE. THE ANALYSIS REVEALED THAT SINCE THESE ACTIONS HAVE BEEN IMPLEMENTED, THERE HAVE BEEN NO MORE RESULTS RELEASED WITH HIGH PIPETTING LEVELS ON THE INSTRUMENT IN QUESTION. THIS ANALYSIS INDICATES THAT THE REPLACEMENT OF THE LLD CABLE AND NEEDLE #1 HAS RESOLVED THE ISSUE, YET THE ROOT CAUSE OF THE POSSIBLE LLD CABLE AND NEEDLE #1 PROBLEM COULD NOT BE ESTABLISHED. THE CUSTOMER HAS PROVIDED VERY LITTLE INFORMATION ABOUT THE PATIENT'S CLINICAL STATUS OR ANY POSSIBLE CONNECTION BETWEEN THE STAGO INSTRUMENT AND THE PATIENT'S ADVERSE EVENT/DEATH. STAGO, THEREFORE, CANNOT ESTABLISH ANY LINKAGE BETWEEN THE ERRONEOUS RESULT AND THE PATIENT'S CLINICAL STATUS (BLOODY STOOLS), THE THERAPEUTIC TREATMENT (NO CHANGE IN THE PATIENT'S TREATMENT), OR THE ADVERSE EVENT. IN ADDITION, THE CUSTOMER HAS NOT REPORTED TO STAGO ANY OTHER INJURIES REGARDING THE LIST OF OTHER PATIENTS POTENTIALLY AFFECTED BY THE ISSUE. STAGO CAN CONCLUDE THAT THERE LIKELY WAS A MALFUNCTION OF THE LLD CABLE AND NEEDLE #1 WHICH LED TO THE ERRONEOUS RESULT ANTI XA <0.10 IU/ML. HOWEVER, THE ROOT CAUSE OF THE MALFUNCTION COULD NOT BE IDENTIFIED AND NO CONNECTION TO THE PATIENT'S ADVERSE EVENT COULD BE ESTABLISHED. STAGO HAS CONCLUDED ITS INVESTIGATION INTO THIS MATTER AND PLANS NO FURTHER ACTION. RELATED REPORT: 8043723-2023-00008. STAGO REFERENCE FILE: (B)(4).
ON (B)(6) 2023, CUSTOMER CALLED TO REPORT ERRONEOUS ANTI-XA (HEPARIN) RESULTS AND THAT THE ORIGINAL RESULT REPORTED WERE <0.10 UI/ML AND THE REPEAT RESULTS AT THEIR SISTER SITE WERE 0.55 UI/ML. ONE PATIENT REPORTEDLY BEGAN TO BLEED. ON (B)(6) 2023, ADDITIONAL INFORMATION WAS PROVIDED. FOR SAMPLE ID (B)(6), PATIENT'S HEPARIN TREATMENT HAD BEEN STOPPED AT 0600 ON (B)(6) 2023, DUE TO BLOOD IN STOOLS. STAGO WAS ALSO NOTIFIED THAT THE PATIENT HAD UNDERGONE A RECENT BOWEL SURGERY. ON THIS DATE ADDITIONAL DOCUMENTS WERE RECEIVED FROM THE CUSTOMER, STATING THAT THERE WERE PRE-EXISTING CONDITIONS AND THAT THE ERRONEOUS RESULTS DID NOT CONTRIBUTE TO INJURY/DEATH. THE ORIGINAL SAMPLE WAS CAPPED AND THE REPEAT RUN AT THE SISTER SITE WAS FROM THE FROZEN ALIQUOT. ON(B)(6) 2023, STAGO WAS NOTIFIED THAT THE PATIENT HAD EXPIRED ON (B)(6) 2023. DIAGNOSTICA STAGO INC, NOTIFIED MANUFACTURER DIAGNOSTICA STAGO S.A.S OF THIS EVENT BY E-MAIL ON (B)(6) 2023. AS OF THIS REPORT, NO OTHER INFORMATION ABOUT THE PATIENT HAS BEEN PROVIDED BY THE CUSTOMER. STAGO'S INVESTIGATION IS ONGOING.
ON (B)(6) 2023, CUSTOMER CALLED TO REPORT ERRONEOUS ANTI-XA (HEPARIN) RESULTS AND THAT THE ORIGINAL RESULT REPORTED WERE <0.10 UL/ML AND THE REPEAT RESULTS AT THEIR SISTER SITE WERE 0.55 UL/ML. ONE PATIENT REPORTEDLY BEGAN TO BLEED. ON 14OCT2023, ADDITIONAL INFORMATION WAS PROVIDED. FOR SAMPLE ID (B)(6), PATIENT'S HEPARIN TREATMENT HAD BEEN STOPPED AT 0600 ON (B)(6) 2023, DUE TO BLOOD IN STOOLS. STAGO WAS ALSO NOTIFIED THAT THE PATIENT HAD UNDERGONE A RECENT BOWEL SURGERY. ON THIS DATE ADDITIONAL DOCUMENTS WERE RECEIVED FROM THE CUSTOMER, STATING THAT THERE WERE PRE-EXISTING CONDITIONS AND THAT THE ERRONEOUS RESULTS DID NOT CONTRIBUTE TO DEATH. THE ORIGINAL SAMPLE WAS CAPPED AND THE REPEAT RUN AT THE SISTER SITE WAS FROM THE FROZEN ALIQUOT. ON19OCT2023, STAGO WAS NOTIFIED THAT THE PATIENT HAD EXPIRED ON (B)(6) 2023. DIAGNOSTICA STAGO INC, NOTIFIED MANUFACTURER DIAGNOSTICA STAGO SAS OF THIS EVENT BY E-MAIL ON 19OCT2023. AS OF THIS REPORT, NO OTHER INFORMATION ABOUT THE PATIENT HAS BEEN PROVIDED BY THE CUSTOMER.
ON (B)(6) 2023, CUSTOMER CALLED TO REPORT ERRONEOUS ANTI-XA (HEPARIN) RESULTS AND THAT THE ORIGINAL RESULT REPORTED WERE <0.10 UL/ML AND THE REPEAT RESULTS AT THEIR SISTER SITE WERE 0.55 UL/ML. ONE PATIENT REPORTEDLY BEGAN TO BLEED. ON 14OCT2023, ADDITIONAL INFORMATION WAS PROVIDED. FOR SAMPLE ID (B)(6), PATIENT'S HEPARIN TREATMENT HAD BEEN STOPPED AT 0600 ON (B)(6) 2023, DUE TO BLOOD IN STOOLS. STAGO WAS ALSO NOTIFIED THAT THE PATIENT HAD UNDERGONE A RECENT BOWEL SURGERY. ON THIS DATE ADDITIONAL DOCUMENTS WERE RECEIVED FROM THE CUSTOMER, STATING THAT THERE WERE PRE-EXISTING CONDITIONS AND THAT THE ERRONEOUS RESULTS DID NOT CONTRIBUTE TO DEATH. THE ORIGINAL SAMPLE WAS CAPPED AND THE REPEAT RUN AT THE SISTER SITE WAS FROM THE FROZEN ALIQUOT. ON (B)(6) 2023, STAGO WAS NOTIFIED THAT THE PATIENT HAD EXPIRED ON (B)(6) 2023. DIAGNOSTICA STAGO INC, NOTIFIED MANUFACTURER DIAGNOSTICA STAGO SAS OF THIS EVENT BY E-MAIL ON 19OCT2023. AS OF THIS REPORT, NO OTHER INFORMATION ABOUT THE PATIENT HAS BEEN PROVIDED BY THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1944261 | STA COMPACT MAX | IVD COAGULATION DEVICE/INSTRUMENT | JPA | DIAGNOSTICA STAGO S.A.S | 58989 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Other| D |