Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY HQ PROCESSING MODULE; COUNTER, DIFFERENTIAL CELL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT LABORATORIES ALINITY HQ PROCESSING MODULE; COUNTER, DIFFERENTIAL CELL Back to Search Results
Catalog Number 09P68-01
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/21/2023
Event Type  malfunction  
Event Description
The customer stated that a user was splashed in the eye with hemoglobin (hgb) reagent while replacing the reagent bottle on the alinity hq processing module.The user immediately used the emergency eye wash station.The emergency response officer at the customer site determined that no medical treatment was required at the time.The individual was wearing a lab coat.No additional personal protective equipment (ppe) such as gloves or mask was used.Troubleshooting identified that the probes for the hgb reagent bottle cradle did not retract during removal of the reagent bottle.Instead, they retracted after the reagent bottle was removed which caused the splashing of reagent into one of the user's eyes.A new hgb reagent cradle was installed to resolve the issue.
 
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Manufacturer Narrative
The complaint investigation for reagent exposure on an alinity hq processing module, serial number (b)(6), included a review of information provided by the field service representative (fsr), a search for similar complaints, ticket trending review, labeling review, and device history record review.It was determined that the cradle needle(s) did not pull in immediately during hgb reagent bottle removal.The cradle needle(s) pulled in after the bottle was removed, causing the splash.The bottle cradle assembly was replaced by the fsr.No subsequent issues have been reported.The part was discarded by the fsr; therefore, return analysis could not be performed.Without the logs and returned part, it could not be confirmed if the code to retract the needles was executed and/or what error was received if any, nor can the cause of the malfunction be determined.A review of the instrument history revealed no contributing factors described in this complaint.A review of labeling and historical data was done, and both were adequate, with no trends found.Based on all available information, no product deficiency was identified.Corrected information in section: g1 contact name, contact office address, contact office email.
 
Event Description
The customer stated that a user was splashed in the eye with hemoglobin (hgb) reagent while replacing the reagent bottle on the alinity hq processing module.The user immediately used the emergency eye wash station.The emergency response officer at the customer site determined that no medical treatment was required at the time.The individual was wearing a lab coat.No additional personal protective equipment (ppe) such as gloves or mask was used.Troubleshooting identified that the probes for the hgb reagent bottle cradle did not retract during removal of the reagent bottle.Instead, they retracted after the reagent bottle was removed which caused the splashing of reagent into one of the user's eyes.A new hgb reagent cradle was installed to resolve the issue.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key17844171
MDR Text Key324598323
Report Number2919069-2023-00031
Device Sequence Number1
Product Code GRZ
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 11/14/2023
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received09/29/2023
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 Received11/09/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/07/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ASSY, BOTTLE CRADLE, CONDUCTIVE SENSING, KEY 2, H-; ASSY, BOTTLE CRADLE, CONDUCTIVE SENSING, KEY 2, H-
-
-