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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD ALINITY I TSH REAGENT KIT

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ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD ALINITY I TSH REAGENT KIT Back to Search Results
Model Number 07P4830
Device Problem Low Test Results (2458)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/23/2020
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 stated that a falsely decreased alinity i tsh result of 0. 1 miu/ml was generated for a patient sample (b)(6). The same sample tube was tested on a different alinity i processing module and the result was 67 miu/ml which matched the clinical picture. No adverse impact to patient management was reported.
 
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Brand NameALINITY I TSH REAGENT KIT
Type of DeviceTSH
Manufacturer (Section D)
ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD
lisnamuck
co. longford
longford NA
EI NA
Manufacturer (Section G)
ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD
lisnamuck
co. longford
longford NA
EI NA
Manufacturer Contact
christian lee
100 abbott park road
dept 09b9, bldg cp01-3
abbott park, IL 60064-3537
224668-294
MDR Report Key9868576
MDR Text Key202533812
Report Number3005094123-2020-00077
Device Sequence Number1
Product Code JLW
Combination Product (y/n)N
Reporter Country CodeFR
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 05/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/16/2021
Device Model Number07P4830
Device Catalogue Number07P48-30
Device Lot Number08228UI00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/21/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/27/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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