ALINITY HQ PROCESSING MODULE
Report
- Report Number
- 2919069-2023-00029
- Event Type
- Malfunction
- Date Received
- September 26, 2023
- Date of Event
- September 18, 2023
- Report Date
- June 26, 2024
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- GKZ
- UDI-DI
- 00380740138851
- PMA / PMN Number
- K220031
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
UPDATED INFORMATION IN SECTION G: CONTACT OFFICE ADDRESS 1, CONTACT OFFICE CITY, CONTACT OFFICE POSTAL CODE, CONTACT OFFICE COUNTRY, CONTACT OFFICE FIRST AND LAST NAME, CONTACT OFFICE EMAIL, CONTACT OFFICE PHONE NUMBER, CONTACT OFFICE FAX NUMBER THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE ALINITY HQ ANALYZER AND REPLACED STAGING TUBING FOR RBC LINE, SMALL CHECK VALVES FOR THE WBC LINE TUBING, THE STAGING PUMP AND SMALL CHECK VALVES, AND WASTE TUBING FROM OPTICS. A LEAKING FITTING CAUSING A PRESSURE/VACUUM LEAK WAS REPLACED. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE FLOW CYTOMETRY STANDARD (FCS) FILES AND THE INITIAL RESULT PRINTOUT FROM THE ALINITY HQ AND THE REPEAT RESULT PRINTOUT FROM THE CELL-DYN SAPPHIRE WERE PROVIDED BY THE CUSTOMER FOR SPECIMEN ID (SID) (B)(6). REVIEW OF THE FCS FILES DETERMINED NO ALGORITHM ISSUE WAS FOUND. REVIEW OF THE PRINTOUTS AND COMPLAINT NOTES CONFIRMED THE RESULT OBSERVED BY THE CUSTOMER. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY HQ ANALYZER, SN (B)(6)WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.
CORRECTION WAS MADE TO FIELD D2B PRO CODE. THE INCORRECT CODE OF GRZ WAS CHANGED TO GKZ. THIS WAS A TYPOGRAPHICAL ERROR CORRECTION AND THERE IS NO FURTHER IMPACT TO THE SUBMISSION. UPDATED INFORMATION IN SECTION D4 PRIMARY UDI NUMBER.
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.
THE CUSTOMER OBSERVED FALSELY DECREASED HEMOGLOBIN RESULTS GENERATED ON THE ALINITY HQ ANALYZER FOR ONE SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6)2023 SID (B)(6)ALINITY HQ INITIAL RESULT 7.9 G/DL, NEW SAMPLE HEMOGLOBIN RESULT WAS 15.6 G/DL (B)(6)2023 SID (B)(6)REPEAT RESULT OF ORIGINAL SAMPLE ON CELL-DYN SAPPHIRE THE NEXT DAY 15.3 G/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
THE CUSTOMER OBSERVED FALSELY DECREASED HEMOGLOBIN RESULTS GENERATED ON THE ALINITY HQ ANALYZER FOR ONE SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2023 SID (B)(6) ALINITY HQ INITIAL RESULT 7.9 G/DL, NEW SAMPLE HEMOGLOBIN RESULT WAS 15.6 G/DL. (B)(6) 2023 SID (B)(6) REPEAT RESULT OF ORIGINAL SAMPLE ON CELL-DYN SAPPHIRE THE NEXT DAY 15.3 G/DL . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
THE CUSTOMER OBSERVED FALSELY DECREASED HEMOGLOBIN RESULTS GENERATED ON THE ALINITY HQ ANALYZER FOR ONE SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2023, SID (B)(6), ALINITY HQ INITIAL RESULT 7.9 G/DL, NEW SAMPLE HEMOGLOBIN RESULT WAS 15.6 G/DL. (B)(6) 2023, SID (B)(6), REPEAT RESULT OF ORIGINAL SAMPLE ON CELL-DYN SAPPHIRE THE NEXT DAY 15.3 G/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1097485 | ALINITY HQ PROCESSING MODULE | COUNTER, DIFFERENTIAL CELL | GKZ | ABBOTT LABORATORIES | 00380740138851 | ||
| 2085014 | ALINITY HQ PROCESSING MODULE | COUNTER, DIFFERENTIAL CELL | GKZ | ABBOTT LABORATORIES | 00380740138851 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |