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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 09/21/2023
Event Type  malfunction  
Event Description
The customer observed falsely depressed neutrophil results generated on the alinity hq processing module for multiple samples.The following data was provided (repeat results were generated on the cell dyn ruby): sid (b)(6): neutrophil result = 0.164 10e3/ul, repeat = 3.74 10e3/ul.Sid (b)(6): neutrophil result = 0.072 10e3/ul, repeat = 17.5 10e3/ul.No impact to patient management was reported.
 
Manufacturer Narrative
Completed information for section a1 patient identifier: sids (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Manufacturer Narrative
Completed information for section a2 and a3 for additional information that was received from the customer: 7 year old male patient: sid (b)(6).10 year old male patient: sid (b)(6).H3 other text : device evaluation still in process.
 
Manufacturer Narrative
Completed information for sections a1 patient identifier: sids (b)(6).Completed information for section a2 and a3: 7 year old male patient: sid (b)(6).10 year old male patient: sid (b)(6).The complaint investigation 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.A review of customer data aligned with the customer¿s issue and no additional issues were identified.In this case, the issue was resolved by replacing the alinity h-series wbc reagent with a new bottle and lot of alinity h-series wbc reagent.A search for similar complaints did not identify an increase in complaint activity.A review of tracking and trending for the alinity h-series wbc reagent 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.Based on our investigation, no systemic issue or deficiency with the alinity hq processing module for serial number (b)(6) or the alinity h-series wbc reagent was identified.
 
Event Description
The customer observed falsely depressed neutrophil results generated on the alinity hq processing module for multiple samples.The following data was provided (repeat results were generated on the cell dyn ruby): sid (b)(6): neutrophil result = 0.164 10e3/ul, repeat = 3.74 10e3/ul.Sid (b)(6): neutrophil result = 0.072 10e3/ul, repeat = 17.5 10e3/ul.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 65205
GM   65205
6122582960
MDR Report Key17915306
MDR Text Key325420981
Report Number2919069-2023-00036
Device Sequence Number1
Product Code GRZ
UDI-Device Identifier00380740138851
UDI-Public00380740138851
Combination Product (y/n)N
Reporter Country CodeID
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,Followup
Report Date 01/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2023
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 Received01/09/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/05/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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