HEMOCHRON WHOLE BLOOD MICROCOAGULATION SYSTEM - HEMOCHRON SIGNATURE ELITE INSTR
Report
- Report Number
- 2250033-2025-00001
- Event Type
- Death
- Date Received
- July 1, 2025
- Date of Event
- June 4, 2025
- Report Date
- July 25, 2025
- Manufacturer
- ACCRIVA DIAGNOSTICS, INC.
- Product Code
- JPA
- UDI-DI
- 10711234510018
- PMA / PMN Number
- K193041
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS MDR REFERENCES ACCRIVA DIAGNOSTICS' COMPLAINT NUMBER (B)(4) FOR THE HEMOCHRON WHOLE BLOOD MICROCOAGULATION SYSTEM - HEMOCHRON SIGNATURE ELITE INSTRUMENT (B)(6). THE INSTRUMENT HAS NO EXPIRATION DATE. ANALYSIS OF PRODUCTION RECORDS DID NOT PROVIDE ANY INFORMATION RELEVANT TO THIS COMPLAINT. THE DHR FOR ELITE INSTRUMENT (B)(6) WAS REVIEWED AND ANALYZED FOR POTENTIAL NON-CONFORMITIES, OR ANOMALIES, WHICH COULD HAVE LED TO THIS COMPLAINT ALLEGATION. REVIEW AND ANALYSIS INDICATED NO NON-CONFORMITIES OR ANOMALIES THAT CAN BE A FACTOR OR A POTENTIAL ROOT CAUSE TO THE AFOREMENTIONED ALLEGATION. THE PRODUCT INITIAL RELEASE TESTING WAS FOUND TO MEET ALL SPECIFICATIONS. ACCRIVA DIAGNOSTICS, INC. HAS REQUESTED FURTHER INFORMATION FROM THE REPORTER AND IS AWAITING A RESPONSE.
FOLLOW-UP 1: FOLLOWING THE INITIAL MDR REPORT, HEMOCHRON SIGNATURE ELITE INSTRUMENT SE12657 WAS RETURNED TO ACCRIVA FOR EVALUATION. THE INSTRUMENT WAS TESTED AND MET ALL TEST CRITERIA. NO ERRORS OCCURRED DURING TESTING, AND THE COMPLAINT COULD NOT BE REPRODUCED. IN ADDITION, A REVIEW OF IN-HOUSE TESTING PERFORMED ON RETAINS OF THE ASSOCIATED CUVETTE LOTS SHOWED THAT THE CUVETTES PERFORMED AS EXPECTED BASED ON ESTABLISHED SPECIFICATIONS: CUVETTE LOT A5JLR015 TESTED UNDER LSR 2025-CSS-058, AND CUVETTE LOT A5JLR011 TESTED UNDER LSR 2025-CSS-050. BASED ON THE INVESTIGATION FINDINGS AND THE INFORMATION AVAILABLE, THE ADVERSE EVENT PROBLEM CODES HAVE BEEN UPDATED AS FOLLOWS: HEALTH EFFECT CLINICAL CODE (E): 4580 - INSUFFICIENT INFORMATION. HEALTH EFFECT IMPACT CODE (F): 1802 - DEATH. MEDICAL DEVICE PROBLEM CODE (A): 3190 - INSUFFICIENT INFORMATION. COMPONENT CODE (G): 593 - ANALYZER. TYPE OF INVESTIGATION (B): 10 - TESTING OF ACTUAL/SUSPECTED DEVICE; 3331 - ANALYSIS OF PRODUCTION RECORDS. INVESTIGATION FINDINGS (C): 213 - NO DEVICE PROBLEM FOUND. INVESTIGATION CONCLUSIONS (D): 4315 - CAUSE NOT ESTABLISHED. THE NUMBER OF PATIENTS AFFECTED REMAINS UNCONFIRMED AS THE INITIAL REPORTER HAS NOT RESPONDED TO ACCRIVA'S REQUEST FOR THIS INFORMATION.
HEALTHCARE PROFESSIONAL REPORTED THAT A HEMOCHRON SIGNATURE ELITE ANALYZER WAS USED ON SEVERAL PATIENT CASES WHERE THEY OBSERVED UNEXPECTED RESULTS. THESE CASES INVOLVED PATIENTS WHO WENT INTO ARREST. ONE PATIENT COULD NOT BE RESUSCITATED, RESULTING IN DEATH. NO ADDITIONAL DETAILS OR PATIENT INFORMATION ARE AVAILABLE AT THIS TIME.
HEALTHCARE PROFESSIONAL REPORTED THAT A HEMOCHRON SIGNATURE ELITE ANALYZER WAS USED ON SEVERAL PATIENT CASES WHERE THEY OBSERVED UNEXPECTED RESULTS. THESE CASES INVOLVED PATIENTS WHO WENT INTO ARREST. ONE PATIENT COULD NOT BE RESUSCITATED, RESULTING IN DEATH. THE NUMBER OF PATIENTS INVOLVED WAS NOT SPECIFIED. THE PATIENT WHO PASSED AWAY WAS UNDERGOING A CORONARY INTERVENTION PROCEDURE. NO ERROR CODES WERE SEEN FROM THE INSTRUMENT, AND ELECTRONIC QUALITY CONTROL (EQC) AND LIQUID QUALITY CONTROL (LQC) TESTING PASSED. NO OTHER MEDICAL OR LABORATORY INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1313535 | HEMOCHRON WHOLE BLOOD MICROCOAGULATION SYSTEM - HEMOCHRON SIGNATURE ELITE INSTR | HEMOCHRON SIGNATURE ELITE | JPA | ACCRIVA DIAGNOSTICS, INC. | ELITE | 10711234510018 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |