ALINITY HQ PROCESSING MODULE
Report
- Report Number
- 2919069-2023-00049
- Event Type
- Malfunction
- Date Received
- December 14, 2023
- Date of Event
- November 14, 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
- NO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETE INFORMATION FOR SECTION A1 PATIENT IDENTIFIER IS 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 COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS GENERATED ON THE ALINITY HQ PROCESSING MODULE, SERIAL NUMBER (B)(6), INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, AND DEVICE HISTORY RECORD REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. REVIEW OF THE DATA FOUND THAT THE LYM, MONO, BASO, RBC, HCT, MCV, MCH, MCHC, RDW, PLT, AND MPV PARAMETERS WERE FLAGGED AS SUSPECT/INVALID AND BLAST, RBC FRAGMENTS, AND BASO BOUNDARY NOT FOUND FLAGS WERE GENERATED FOR ALL SAMPLE RUNS. ADDITIONALLY, MONO BOUNDARY NOT FOUND FLAG WAS GENERATED FOR SEQ 88893 AND PLT CLUMP FLAG WAS GENERATED FOR SEQ 89024. REVIEW THE RESULTS BETWEEN SAMPLE ID (B)(6) (ASSUMING TWO DIFFERENT SAMPLES FROM THE SAME PATIENT) FOUND WBC, RBC, HGB, PLT WERE ALL LOWER FOR THE SECOND SAMPLE (ID (B)(6)). REVIEW OF THE FCS FILES FOR BOTH SAMPLES FOUND THAT THERE WAS NO CLEAR SEPARATION BETWEEN NEU, MONO, AND LYM POPULATIONS. BLAST FLAGGING WAS GENERATED. PER THE OPERATOR¿S MANUAL, BLAST CELLS CAN MAKE SOME WBC DIFFERENTIAL RESULTS SUSPECT OR INVALID BASED ON THE NUMBER OF BLASTS. IN THIS CASE, THE MONO COUNTS WERE INVALIDATED AND LYM RESULTS WERE SUSPECTED. WHEN WBC DIFFERENTIAL WAS INVALIDATED/SUSPECTED FOR ANY PART, THE VERIFICATION OF ALL WBC DIFFERENTIALS WOULD BE REQUIRED. BASED ON THE INFORMATION PROVIDED, THE SPECIFIC PATHOLOGY OF THIS SAMPLE COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR TO THE CAUSE OF THIS ISSUE. THE ALINITY HQ GENERATED MORPHOLOGICAL FLAGGING AND MARKED THE RESULTS AS SUSPECT, INDICATING THAT VERIFICATION OF THE RESULTS WAS REQUIRED. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY HQ PROCESSING MODULE FOR SERIAL NUMBER (B)(6) WAS IDENTIFIED.
THE CUSTOMER OBSERVED IMPRECISE NEUTROPHIL COUNTS AND HEMOGLOBIN RESULTS FOR ONE PATIENT ON AN ALINITY HQ ANALYZER. THE PATIENT HAS MDS AND THE CUSTOMER EXPECTED THE NEUTROLPHIL RESULTS TO BE FLAGGED AND INVALIDATED ON THE ALINITY HQ. THE SAME PATIENT WAS RAN IN DUPLICATE TWO DAYS IN A ROW WITH VARYING NEUTROPHIL AND HEMOGLOBIN RESULTS. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE FOR NEUTROPHIL IS 1.8-6.9 10E9/L): SID (B)(6) (B)(6) 2023 10:13AM NEUT = 0.094 X10^9/L HEMOGLOBIN RESULT = 10.2 G/DL. SID (B)(6) (B)(6) 2023 10:17AM NEUT = 2.11 X10^9/L HEMOGLOBIN RESULT = 10.2 G/DL. SID (B)(6) (B)(6) 2023 10:17AM NEUT = 1.59 X10^9/L HEMOGLOBIN RESULT = 7.90 G/DL. SID (B)(6) (B)(6) 2023 10:17AM NEUT = 0.294 X10^9/L HEMOGLOBIN RESULT = 7.96 G/DL THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
THE CUSTOMER OBSERVED IMPRECISE NEUTROPHIL COUNTS AND HEMOGLOBIN RESULTS FOR ONE PATIENT ON AN ALINITY HQ ANALYZER. THE PATIENT HAS MDS AND THE CUSTOMER EXPECTED THE NEUTROLPHIL RESULTS TO BE FLAGGED AND INVALIDATED ON THE ALINITY HQ. THE SAME PATIENT WAS RAN IN DUPLICATE TWO DAYS IN A ROW WITH VARYING NEUTROPHIL AND HEMOGLOBIN RESULTS. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE FOR NEUTROPHIL IS 1.8-6.9 10E9/L): SID (B)(6),ON (B)(6) 2023 ,10:13AM NEUT = 0.094 X10^9/L HEMOGLOBIN RESULT = 10.2 G/DL. SID (B)(6), ON (B)(6) 2023 ,10:17AM NEUT = 2.11 X10^9/L HEMOGLOBIN RESULT = 10.2 G/DL. SID (B)(6) , ON (B)(6) 2023, 10:17AM NEUT = 1.59 X10^9/L HEMOGLOBIN RESULT = 7.90 G/DL. SID (B)(6), ON (B)(6) 2023, 10:17AM NEUT = 0.294 X10^9/L HEMOGLOBIN RESULT = 7.96 G/DL THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
THE CUSTOMER OBSERVED IMPRECISE NEUTROPHIL COUNTS AND HEMOGLOBIN RESULTS FOR ONE PATIENT ON AN ALINITY HQ ANALYZER. THE PATIENT HAS MDS AND THE CUSTOMER EXPECTED THE NEUTROLPHIL RESULTS TO BE FLAGGED AND INVALIDATED ON THE ALINITY HQ. THE SAME PATIENT WAS RAN IN DUPLICATE TWO DAYS IN A ROW WITH VARYING NEUTROPHIL AND HEMOGLOBIN RESULTS. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL RANGE FOR NEUTROPHIL IS 1.8-6.9 10E9/L): SID (B)(6) 14NOV2023 10:13AM NEUT = 0.094 X10^9/L HEMOGLOBIN RESULT = 10.2 G/DL. SID (B)(6) 14NOV2023 10:17AM NEUT = 2.11 X10^9/L HEMOGLOBIN RESULT = 10.2 G/DL. SID (B)(6) 15NOV2023 10:17AM NEUT = 1.59 X10^9/L HEMOGLOBIN RESULT = 7.90 G/DL. SID (B)(6) 15NOV2023 10:17AM NEUT = 0.294 X10^9/L HEMOGLOBIN RESULT = 7.96 G/DL THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1227417 | ALINITY HQ PROCESSING MODULE | COUNTER, DIFFERENTIAL CELL | GKZ | ABBOTT LABORATORIES | 00380740138851 | ||
| 266450 | ALINITY HQ PROCESSING MODULE | COUNTER, DIFFERENTIAL CELL | GKZ | ABBOTT LABORATORIES | 00380740138851 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |