ALINITY HQ PROCESSING MODULE
Report
- Report Number
- 2919069-2023-00042
- Event Type
- Malfunction
- Date Received
- October 18, 2023
- Date of Event
- October 2, 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
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE INVESTIGATION INCLUDED A REVIEW OF PRODUCT HISTORICAL DATA, PRODUCT LABELING AND TRACKING AND TRENDING FOR ALINITY HQ PROCESSING MODULE. A REVIEW WAS PERFORMED FOR ANY TRENDS AND ALL CUSTOMER COMPLAINTS RECEIVED FOR THIS ISSUE. THE REVIEW OF THIS DATA DID NOT IDENTIFY ANY TRENDS OR ABNORMAL COMPLAINT ACTIVITY. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A FLOW DETECTION FAULT ON WASTE TANK 2 WAS DETERMINED AND THE WASTE TANK 2 WAS REPLACED BY FIELD SERVICE, RESOLVING THE ISSUE OF FALSELY LOW RESULTS ON THE ALINITY HQ, SERIAL NUMBER (B)(6). A REVIEW OF THE PRODUCT HISTORICAL DATA DID NOT FIND A PRODUCT ISSUE RELATED TO THE COMPLAINT INCIDENT. A LABELING WAS FOUND TO BE ADEQUATE FOR THE COMPLAINT ISSUE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY OF THE ALINITY HQ PROCESSING MODULE, LIST NUMBER 09P68, SERIAL NUMBER (B)(6), WAS IDENTIFIED. THE FOLLOWING SECTIONS HAVE BEEN CORRECTED TO REFLECT THE CURRENT CONTACT (B)(6).
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETE INFORMATION FOR SECTION A1 PATIENT IDENTIFIER = SID (B)(6) AND SID (B)(6).
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. ADDITIONAL INFORMATION PROVIDED IN SECTION D4 PRIMARY UDI NUMBER: (B)(4)
THE CUSTOMER OBSERVED FALSELY DECREASED HEMOGLOBIN RESULTS ON THE ALINITY HQ, SERIAL NUMBER (B)(6), FOR TWO PATIENTS. THE RESULTS WERE NOT REPORTED OUT. THE SAMPLE WAS REPEATED ON ANOTHER ALINITY HQ, (B)(6) WITH EXPECTED RESULTS. THE FOLLOWING DATA FROM (B)(6) 2023 WAS PROVIDED: (B)(6): SID (B)(6) HGB = 7.60. SID (B)(6) HGB = 5.61. (B)(6): SID (B)(6) HGB = 12.8. SID (B)(6) HGB = 9.81 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
THE CUSTOMER OBSERVED FALSELY DECREASED HEMOGLOBIN RESULTS ON THE ALINITY HQ, SERIAL NUMBER (B)(6) , FOR TWO PATIENTS. THE RESULTS WERE NOT REPORTED OUT. THE SAMPLE WAS REPEATED ON ANOTHER ALINITY HQ, HQ00503 WITH EXPECTED RESULTS. THE FOLLOWING DATA FROM (B)(6) 2023 WAS PROVIDED: HQ00501: SID (B)(6) HGB = 7.60. SID (B)(6) HGB = 5.61. HQ00503: SID (B)(6) HGB = 12.8. SID (B)(6) HGB = 9.81 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
THE CUSTOMER OBSERVED FALSELY DECREASED HEMOGLOBIN RESULTS ON THE ALINITY HQ, SERIAL NUMBER (B)(6) , FOR TWO PATIENTS. THE RESULTS WERE NOT REPORTED OUT. THE SAMPLE WAS REPEATED ON ANOTHER ALINITY HQ, (B)(6) WITH EXPECTED RESULTS. THE FOLLOWING DATA FROM (B)(6) 2023 WAS PROVIDED: (B)(6) : SID (B)(6) HGB = 7.60, SID (B)(6) HGB = 5.61. (B)(6) : SID (B)(6) HGB = 12.8 SID (B)(6) HGB = 9.81 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1227414 | ALINITY HQ PROCESSING MODULE | COUNTER, DIFFERENTIAL CELL | GKZ | ABBOTT LABORATORIES | 00380740138851 | ||
| 176441 | ALINITY HQ PROCESSING MODULE | COUNTER, DIFFERENTIAL CELL | GKZ | ABBOTT LABORATORIES | 00380740138851 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | ASSY, WASTE BTL, 1L, FLOAT LEVEL SWITCH, PPRO, H-3| ASSY, WASTE BTL, 1L, FLOAT LEVEL SWITCH, PPRO, H-3| ASSY, WASTE BTL, 1L, FLOAT LEVEL SWITCH, PPRO, H-3 |