ALINITY HQ PROCESSING MODULE
Report
- Report Number
- 2919069-2024-00013
- Event Type
- Malfunction
- Date Received
- February 12, 2024
- Date of Event
- January 15, 2024
- Report Date
- July 1, 2024
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- GKZ
- PMA / PMN Number
- K220031
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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.
REVIEW OF THE DATA AND SCATTER IMAGES FROM THE RESULT REPORTS DETERMINED THE INITIAL DSS READING WAS TOO HIGH FOR EACH SAMPLE, WHICH CAUSES THE NEU POPULATION TO SHIFT INTO THE EOS REGION, LEADING TO ELEVATED EOS RESULTS. THE NEU AND EOS RESULTS FROM THE INITIAL RUN FOR PATIENT 1 WERE INVALIDATED, INDICATING THE RESULTS REQUIRED VERIFICATION; HOWEVER, NO FLAGS/MESSAGES WERE OBSERVED FROM THE INITIAL RUNS FOR PATIENT 2. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE INSTRUMENT SERVICE HISTORY REVIEW FOR (B)(6) REVEALED NO ADDITIONAL SERVICE TICKETS ASSOCIATED WITH DISCREPANT/ERRATIC RESULTS. THERE WERE NO ADDITIONAL SERVICE OR COMPLAINT ISSUES ON OR AROUND THE DATE THIS COMPLAINT WAS INITIATED THAT MAY HAVE CONTRIBUTED TO THIS ISSUE. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY HQ PROCESSING MODULE DID NOT IDENTIFY ANY TRENDS. REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY HQ PROCESSING MODULE FOR SERIAL (B)(6) WAS IDENTIFIED.
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
THE CUSTOMER OBSERVED FALSELY DEPRESSED NEUTROPHILS GENERATED ON THE ALINITY HQ PROCESSING MODULE FOR THE FOLLOWING PATIENT SAMPLES. SID (B)(6), HQ00634, NEU .001, EOS 7.44. REPEATED NEU 7.34, EOS .085. REPEATED NEU 7.44, EOS .088. SID (B)(6), NEU .001, EOS 1.72. REPEATED NEU 1.56, EOS .212. SID (B)(6), NEU .003 EOS 2.94. REPEATED NEU 2.84, EOS .132. SID: (B)(6), NEU 0.001, EOS 4.22. REPEATED NEU 3.81 EOS 0.286 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
THE CUSTOMER OBSERVED FALSELY DEPRESSED NEUTROPHILS GENERATED ON THE ALINITY HQ PROCESSING MODULE FOR THE FOLLOWING PATIENT SAMPLES. SID (B)(6). (B)(6). NEU .001. EOS 7.44. REPEATED. NEU 7.34. EOS .085. REPEATED. NEU 7.44. EOS .088. SID (B)(6). NEU .001. EOS 1.72. REPEATED. NEU 1.56. EOS .212. SID (B)(6). NEU .003. EOS 2.94. REPEATED. NEU 2.84. EOS .132. SID: (B)(6). NEU 0.001. EOS 4.22. REPEATED. NEU 3.81. EOS 0.286 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
THE CUSTOMER OBSERVED FALSELY DEPRESSED NEUTROPHILS GENERATED ON THE ALINITY HQ PROCESSING MODULE FOR THE FOLLOWING PATIENT SAMPLES. SID (B)(6), (B)(6) , NEU .001, EOS 7.44, REPEATED, NEU 7.34, EOS .085, REPEATED, NEU 7.44, EOS .088. SID (B)(6), NEU .001, EOS 1.72, REPEATED, NEU 1.56, EOS .212. SID (B)(6), NEU .003, EOS 2.94, REPEATED, NEU 2.84 , EOS .132. SID: (B)(6), NEU 0.001, EOS 4.22, REPEATED, NEU 3.81, EOS 0.286 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1397780 | ALINITY HQ PROCESSING MODULE | COUNTER, DIFFERENTIAL CELL | GKZ | ABBOTT LABORATORIES | |||
| 2192755 | ALINITY HQ PROCESSING MODULE | COUNTER, DIFFERENTIAL CELL | GKZ | ABBOTT LABORATORIES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |