ALINITY HQ PROCESSING MODULE
Report
- Report Number
- 2919069-2023-00037
- Event Type
- Malfunction
- Date Received
- October 12, 2023
- Date of Event
- October 10, 2023
- Report Date
- June 27, 2024
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- GKZ
- UDI-DI
- 00380740138851
- PMA / PMN Number
- K220031
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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.
THE ALINITY HQ PROCESSING MODULE SERIAL NUMBER (B)(6) WAS INSPECTED, AND IT WAS NOTED THAT MULTIPLE VARIOUS TUBING, VALVES, AND CHECK VALVES IN AREAS OF THE INJECTION MANIFOLD AND STAGING PUMP REQUIRED REPLACEMENT, AND CLEANING OF THE ANALYZER WAS PERFORMED. QUALITY CONTROL RUNS WERE THEN REPORTEDLY OK. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. A REVIEW OF TICKET TRACKING AND TRENDING DID NOT IDENTIFY A TREND FOR THE ALINITY HQ PROCESSING MODULE, NOR WAS AN INCREASE IN COMPLAINT ACTIVITY FOUND. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY PRODUCT ISSUES. LABELING WAS REVIEWED AND WAS FOUND TO ADDRESS THE CUSTOMER REPORTED ISSUE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE ALINITY HQ PROCESSING MODULE SERIAL NUMBER (B)(6).
A1 PATIENT IDENTIFIER: COMPLETE SAMPLE ID'S ARE (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
THE CUSTOMER REPORTED FALSELY LOW WHITE BLOOD CELLS GENERATED FROM AN ALINITY HQ PROCESSING MODULE AND PROVIDED THE FOLLOWING RESULTS. ON (B)(6) 2023, SAMPLE ID (B)(6) INITIAL NEUTROPHIL COUNT WAS 0.12 10E3/UL AND REPEAT RESULT WAS 4.73 10E3/UL ON (B)(6) 2023, SAMPLE ID (B)(6) INITIAL WBC WAS 0.764 10E3/UL, REPEAT TEST WAS 4.12 10E3/UL. ADDITIONALLY, THE INITIAL NEUTROPHIL COUNT WAS 0.01 10E3/UL AND REPEAT RESULT WAS 1.75 10E3/UL. PER THE CUSTOMER NO DISCREPANT RESULTS WERE REPORTED TO THE PATIENT¿S MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
THE CUSTOMER REPORTED FALSELY LOW WHITE BLOOD CELLS GENERATED FROM AN ALINITY HQ PROCESSING MODULE AND PROVIDED THE FOLLOWING RESULTS. ON (B)(6) 2023, SAMPLE ID (B)(6) INITIAL NEUTROPHIL COUNT WAS 0.12 10E3/UL AND REPEAT RESULT WAS 4.73 10E3/UL. ON (B)(6) 2023, SAMPLE ID (B)(6) INITIAL WBC WAS 0.764 10E3/UL, REPEAT TEST WAS 4.12 10E3/UL. ADDITIONALLY, THE INITIAL NEUTROPHIL COUNT WAS 0.01 10E3/UL AND REPEAT RESULT WAS 1.75 10E3/UL. PER THE CUSTOMER NO DISCREPANT RESULTS WERE REPORTED TO THE PATIENT¿S MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
THE CUSTOMER REPORTED FALSELY LOW WHITE BLOOD CELLS GENERATED FROM AN ALINITY HQ PROCESSING MODULE AND PROVIDED THE FOLLOWING RESULTS. ON (B)(6) 2023, SAMPLE ID (B)(6) INITIAL NEUTROPHIL COUNT WAS 0.12 10E3/UL AND REPEAT RESULT WAS 4.73 10E3/UL ON (B)(6) 2023, SAMPLE ID (B)(6) INITIAL WBC WAS 0.764 10E3/UL, REPEAT TEST WAS 4.12 10E3/UL. ADDITIONALLY, THE INITIAL NEUTROPHIL COUNT WAS 0.01 10E3/UL AND REPEAT RESULT WAS 1.75 10E3/UL. PER THE CUSTOMER NO DISCREPANT RESULTS WERE REPORTED TO THE PATIENT¿S MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1227412 | ALINITY HQ PROCESSING MODULE | COUNTER, DIFFERENTIAL CELL | GKZ | ABBOTT LABORATORIES | 00380740138851 | ||
| 1505890 | ALINITY HQ PROCESSING MODULE | COUNTER, DIFFERENTIAL CELL | GKZ | ABBOTT LABORATORIES | 00380740138851 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |