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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 Installation-Related Problem (2965)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer reported that after a software update to version 5.4, which was performed by abbott, their normal unit of measure on the alinity hq processing module was not retained.The customer provided the following data for the change of the unit of measure: the customer¿s normal unit of measure for hemoglobin (hgb) is mmol/l and after the software update the hgb unit of measure was g/dl.The customer communicated that initially they only looked at the number and not the number and the unit of measure together, which resulted in an initial misinterpretation of results.The customer provided 5 measurements as g/dl (8.48 g/dl ; 7.91 g/dl ; 10.1 g/dl; 13.8 g/dl ; 9.31 g/dl).After conversion to the normal unit of measure, the customer confirmed that there were no missed transfusions.The customer stated that 1 patient did require to have another blood draw due to the misinterpretation of results.The customer reported that there was no further reported impact to patient management.
 
Manufacturer Narrative
The alinity hq, serial number (b)(6) was inspected and it was noted that the units of measure should be captured before a software update and verified after update is completed.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A review of ticket tracking and trending did not identify a trend for the alinity hq, nor was an increase in complaint activity found.A review of the manufacturing documentation did not identify any non-conformances or potential non-conformances related to the alinity hq and customer reported event.Labeling was reviewed and was found to address the customer reported issue.Based on the available information, no systemic issue or deficiency was identified for the alinity hq, serial number (b)(6).
 
Event Description
The customer reported that after a software update to version 5.4, which was performed by abbott, their normal unit of measure on the alinity hq processing module was not retained.The customer provided the following data for the change of the unit of measure: the customer¿s normal unit of measure for hemoglobin (hgb) is mmol/l and after the software update the hgb unit of measure was g/dl.The customer communicated that initially they only looked at the number and not the number and the unit of measure together, which resulted in an initial misinterpretation of results.The customer provided 5 measurements as g/dl (8.48 g/dl ; 7.91 g/dl ; 10.1 g/dl; 13.8 g/dl ; 9.31 g/dl).After conversion to the normal unit of measure, the customer confirmed that there were no missed transfusions.The customer stated that 1 patient did require to have another blood draw due to the misinterpretation of results.The customer reported that there was no further reported impact to patient management.
 
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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 N39 E-932
GM   N39 E932
6122582960
MDR Report Key17928259
MDR Text Key325687071
Report Number2919069-2023-00038
Device Sequence Number1
Product Code GRZ
UDI-Device Identifier00380740138851
UDI-Public00380740138851
Combination Product (y/n)N
Reporter Country CodeNL
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 01/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2023
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
Date Manufacturer Received01/10/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/08/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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