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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 02/13/2024
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
 
Event Description
The customer observed falsely decreased hemoglobin results generated on the alinity hq processing module for a patient sample.The following data was provided: initial result = 50 g/l (5 g/dl), repeat on another analyzer = 120 g/l (12 g/dl) no impact to patient management was reported.
 
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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 Key18836398
MDR Text Key336885622
Report Number2919069-2024-00021
Device Sequence Number1
Product Code GRZ
UDI-Device Identifier00380740138851
UDI-Public00380740138851
Combination Product (y/n)N
Reporter Country CodeUK
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
Report Date 03/05/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2024
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 Received02/15/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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