ALINITY HQ PROCESSING MODULE
Report
- Report Number
- 2919069-2024-00040
- Event Type
- Malfunction
- Date Received
- June 24, 2024
- Date of Event
- May 29, 2024
- Report Date
- September 12, 2024
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- GKZ
- UDI-DI
- 00380740138851
- PMA / PMN Number
- K220031
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED . IN BOTH SEQ (B)(6) AND (B)(6), THE PLT CLUMP FLAG WAS GENERATED AND THE PLT PARAMETER WAS FLAGGED AS INVALID DATA. SEQ (B)(6) ALSO HAD THE MPV PARAMETER FLAGGED AS INVALID, BUT THE MPV PARAMETER DATA WAS NOT PROVIDED FOR SEQ (B)(6). WBC, NEU, BASO, RBC, HGB, AND HCT WERE FLAGGED AS OUT OF RANGE LOW, WHILE LYM, IG, MCV, MCH, AND RDW WERE FLAGGED AS OUT OF RANGE HIGH, FOR SEQ (B)(6). FOR SEQ (B)(6) , THE MONO, BASO, RBC, HGB, AND HCT PARAMETERS WERE FLAGGED AS OUT OF RANGE LOW, WHILE THE IG, MCV, MCH, AND RDW PARAMETERS WERE FLAGGED OUT OF RANGE HIGH. REVIEW OF THE FLOW CYTOMETRY STANDARD (FCS) FILES INDICATED THE FL1 CHANNELS FOR THE NEUTROPHIL POPULATION OF THESE SAMPLES WERE OVERLY VERY LOW COMPARED TO THE FL1 VALUE WHICH THE NORMAL NEUTROPHILS SHOULD HAVE, SUCH THAT PORTIONS OF THE WBC CELLS FELL INTO THE PLT CLUMPS DETECTION REGIONS, RESULTING IN BEING MISCLASSIFIED EITHER AS PLT CLUMPS OR AS DEBRIS, AND WBC COUNTS WERE FALSELY DECREASED. BASED ON THE INFORMATION PROVIDED, THE ISSUE MIGHT BE DUE TO THE SAMPLE PATHOLOGIES. PLT CLUMPS ARE A KNOWN INTERFERING SUBSTANCE FOR WBC AND WBC DIFFERENTIALS. THE RESULTS WERE INVALIDATED OR ALERTED, INDICATING THE VERIFICATION OF THE RESULTS WAS REQUIRED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. NO SMEAR IMAGES WERE PROVIDED TO CHECK THE SAMPLE MORPHOLOGIES. A REVIEW OF COMPLAINTS ASSOCIATED WITH THE ALINITY HQ PROCESSING MODULE AND A REVIEW OF COMPLAINT TRENDS FOR THE LIST NUMBER WAS PERFORMED. THE REVIEW DID NOT IDENTIFY ANY TRENDS OR ABNORMAL COMPLAINT ACTIVITY. ADDITIONALLY, LABELING WAS REVIEWED AND ADEQUATELY ADDRESSED THE ISSUE UNDER REVIEW. REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED.
THE MOST PROBABLE ROOT CAUSES ASSOCIATED WITH THIS FAILURE MODE ARE DISCONNECTED, FAULTY OR DAMAGED COMPONENTS, SOFTWARE/DATA CORRUPTION, OR MISUSE. HOWEVER, MITIGATIONS ARE IN PLACE TO REDUCE AND PREVENT SUCH ISSUES. ALL VITAL MANUFACTURING STEPS ARE VALIDATED, MONITORED, AND VERIFIED DURING MANUFACTURING TO ENSURE THE SYSTEM IS IN CONFORMANCE WITH THE VERIFIED DESIGN. ALL VITAL FUNCTIONS ARE MONITORED BY THE SYSTEM AND, WHEN NECESSARY, FUNCTION IS SUSPENDED TO SAFEGUARD AGAINST INACCURATE RESULTS. LABELING IS PROVIDED TO INSTRUCT THE USER ON THE INTENDED USE OF ALL VITAL PARTS OF THE SYSTEM TO MINIMIZE MISUSE. ALL COMPLAINTS AND COMPLAINT TRENDS ARE INVESTIGATED TO DETERMINE IF THERE IS A PRODUCT DEFECT/ DEFICIENCY. IF A PRODUCT DEFECT/ DEFICIENCY IS IDENTIFIED, A RISK EVALUATION IS COMPLETED AND COMPARED TO THE RISK MANAGEMENT REPORT, TO ENSURE THE RISK PROFILE HAS NOT CHANGED. ADDITIONALLY, AS A PART OF ABBOTT¿S POST-MARKET SURVEILLANCE PROCESS, ALL RISK EVALUATIONS WITH ASSOCIATED COMPLAINT DATA ARE REVIEWED ANNUALLY TO DETERMINE IF THE RISK PROFILES HAVE CHANGED AS COMPARED TO THE PRODUCT RISK MANAGEMENT REPORTS. THESE MONITORING PROCESSES ENSURE THAT ALL PRODUCT RISK PROFILES REMAIN ACCEPTABLE AND HAVE A POSITIVE BENEFIT/ RISK RATIO. AT THIS TIME PRODUCT HAS NOT YET BEEN RETURNED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. THE DEVICE HISTORY RECORDS (DHRS) FOR THE FREESTYLE LIBRE SENSOR AND FREESTYLE LIBRE SENSOR KIT WERE REVIEWED AND THE DHRS SHOWED THE FREESTYLE LIBRE SENSOR AND SENSOR KIT PASSED ALL TESTS PRIOR TO RELEASE. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED. THE DATE OF EVENT IS UNKNOWN. THE DATE ENTERED IN SECTION B3 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
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. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION HAS BEEN INCLUDED. NO ADDITIONAL PATIENT DETAILS ARE AVAILABLE.
THE CUSTOMER OBSERVED FALSELY DEPRESSED NEUTROPHILS GENERATED ON THE ALINITY HQ PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIALLY RUN ON (B)(6) (B)(6) 2024. NEU .476L 10E3/UL. 2ND RUN ON (B)(6) (B)(6) 2024. NEU 3.32 10E3/UL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
THE CUSTOMER OBSERVED FALSELY DEPRESSED NEUTROPHILS GENERATED ON THE ALINITY HQ PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIALLY RUN ON (B)(6) 28MAY2024. NEU .476L 10E3/UL. 2ND RUN ON(B)(6) 29MAY2024. NEU 3.32 10E3/UL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
THE CUSTOMER OBSERVED FALSELY DEPRESSED NEUTROPHILS GENERATED ON THE ALINITY HQ PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIALLY RUN ON (B)(6), (B)(6) 2024. NEU .476L 10E3/UL 2ND RUN ON (B)(6). (B)(6) 2024. NEU 3.32 10E3/UL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 481320 | ALINITY HQ PROCESSING MODULE | COUNTER, DIFFERENTIAL CELL | GKZ | ABBOTT LABORATORIES | 00380740138851 | ||
| 625041 | ALINITY HQ PROCESSING MODULE | COUNTER, DIFFERENTIAL CELL | GKZ | ABBOTT LABORATORIES | 00380740138851 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |