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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY I PROCESSING MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
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ABBOTT LABORATORIES ALINITY I PROCESSING MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE Back to Search Results
Catalog Number 03R65-01
Device Problem Leak/Splash (1354)
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 follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer reported that she was splashed in the left eye while checking the wash zone pump in the back of the alinity i processing module.The analyzer was in the stop status due to the wash zone 1 pump fill error.The customer stated while she was pulling out the drawer for buffer dilution/pump & syringe assembly, one of the tubing connected to the buffer reservoir was loose and splashed fluid into her left eye.She was wearing safety glasses at the time of the incident but some fluid still got into her eye.The customer flushed her eyes with water but did not seek any medical treatment.Customer stated that she is fine and do not have any eye irritations.There was no further impact to the user.There was impact to patient management reported.
 
Manufacturer Narrative
The instrument experienced error code 3421, wash zone pump fill error, while using alinity i concentrated wash buffer, lot number 55493fn01.The customer was checking the wash zone pump when fluid inside the tubing splashed into the customer¿s left eye.The customer was wearing safety glasses at the time of the incident.The data and information provided by the customer were reviewed and support the complaint issue.A ticket search by lot indicates that the reagent lot performs as expected for this product.A review of the complaint trending report did not identify any trends for the issue for the product.A review of the device history record did not identify any non-conformances or deviations associated with the likely cause lot number and complaint issue.A review of labeling was performed and found to sufficiently address the customer's issue.The safety data sheet for alinity i-series concentrated wash buffer, section 8, exposure control/personal protection outlines the requirements for personal protective equipment to be worn on use of this product, ¿wear safety glasses or other protective eyewear.If splash potential exists, wear full face shield or goggles.¿ based on the investigation, no systemic issue or deficiency was identified for the alinity i processing module serial number (b)(6) or the concentrated wash buffer lot number 55493fn01.
 
Event Description
The customer reported that she was splashed in the left eye while checking the wash zone pump in the back of the alinity i processing module.The analyzer was in the stop status due to the wash zone 1 pump fill error.The customer stated while she was pulling out the drawer for buffer dilution/pump & syringe assembly, one of the tubing connected to the buffer reservoir was loose and splashed fluid into her left eye.She was wearing safety glasses at the time of the incident but some fluid still got into her eye.The customer flushed her eyes with water but did not seek any medical treatment.Customer stated that she is fine and do not have any eye irritations.There was no further impact to the user.There was impact to patient management reported.
 
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Brand Name
ALINITY I PROCESSING MODULE
Type of Device
ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
Manufacturer (Section D)
ABBOTT LABORATORIES
1915 hurd drive
irving TX 75038
Manufacturer (Section G)
ABBOTT LABORATORIES
1915 hurd drive
irving TX 75038
Manufacturer Contact
nicole jenne
max-planck-ring 2
post market surveillance
wiesbaden 65205
GM   65205
6122582960
MDR Report Key18797729
MDR Text Key336507621
Report Number3016438761-2024-00121
Device Sequence Number1
Product Code JJE
UDI-Device Identifier00380740137366
UDI-Public(01)00380740137366
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
EXEMPT
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 03/27/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03R65-01
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/22/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/06/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ALNTY I-SERIES CONC WAS, 06P13-68, 55493FN01; ALNTY I-SERIES CONC WAS, 06P13-68, UNKNOWN
Patient SexFemale
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