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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY HQ PROCESSING MODULE; COUNTER, DIFFERENTIAL CELL
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ABBOTT LABORATORIES ALINITY HQ PROCESSING MODULE; COUNTER, DIFFERENTIAL CELL Back to Search Results
Catalog Number 09P68-01
Device Problem Low Test Results (2458)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/19/2023
Event Type  malfunction  
Event Description
The customer observed falsely decreased hemoglobin results generated on the alinity hq analyzer for two patients.The hemoglobin results were not consistent with the patients¿ historical results.The same samples were repeated on another alinity hq analyzer and the results matched up with the patients¿ historical results.The following data was provided: patient 1: sample number (b)(6).Initial hemoglobin result = 60.0 g/l.Repeat hemoglobin result on the same analyzer = 127.0 g/l.Repeat hemoglobin result on another alinity hq (hq00903) = 125.0 g/l.Patient 2: sample number (b)(6).Initial hemoglobin result = 76.3 g/l.Repeat hemoglobin result on another alinity hq (hq00903) = 153.0 g/l.No impact to patient management was reported.
 
Manufacturer Narrative
Section a1 - patient identifier: (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer observed falsely decreased hemoglobin results generated on the alinity hq analyzer for two patients.The hemoglobin results were not consistent with the patients¿ historical results.The same samples were repeated on another alinity hq analyzer and the results matched up with the patients¿ historical results.The following data was provided: patient 1: sample number (b)(6).Initial hemoglobin result = 60.0 g/l.Repeat hemoglobin result on the same analyzer = 127.0 g/l.Repeat hemoglobin result on another alinity hq (hq00903) = 125.0 g/l.Patient 2: sample number (b)(6).Initial hemoglobin result = 76.3 g/l.Repeat hemoglobin result on another alinity hq (hq00903) = 153.0 g/l.No impact to patient management was reported.
 
Manufacturer Narrative
The field service representative (fsr) inspected the instrument and replaced various tubing for the waste tank and waste subsystem and valves v92 and v94 which resolved the issue.Return testing was not completed as returns were not available.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) were identified.
 
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Brand Name
ALINITY HQ PROCESSING MODULE
Type of Device
COUNTER, DIFFERENTIAL CELL
Manufacturer (Section D)
ABBOTT LABORATORIES
4551 great america parkway
santa clara CA 95054
Manufacturer (Section G)
ABBOTT LABORATORIES
4551 great america parkway
santa clara CA 95054
Manufacturer Contact
nicole jenne
max-planck-ring 2
post market surveillance
wiesbaden 65205
GM   65205
6122582960
MDR Report Key17884651
MDR Text Key325071197
Report Number2919069-2023-00034
Device Sequence Number1
Product Code GRZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K220031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/07/2023
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number09P68-01
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/20/2023
Initial Date FDA Received10/06/2023
Supplement Dates Manufacturer Received11/29/2023
Supplement Dates FDA Received12/07/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/18/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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