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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: A.I.D.D LONGFORD ALINITY I TSH REAGENT
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A.I.D.D LONGFORD ALINITY I TSH REAGENT Back to Search Results
Catalog Number 07P48-20
Device Problem Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
All available patient informatin has been included.No additional patient details are available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer reported a false decreased tsh result when processing on the alinity i.The initial result was less than 0.01 and retest result was 1.57 miu/l.No impact to patient management was reported.
 
Manufacturer Narrative
After further evaluation, the suspect medical device was changed from alinity i tsh reagent, ln 07p48-20, manufacturing site a.I.D.D longford, longford to alinity ci-series level sensor, bulk solution, ln 04s68-02, manufacturing site abbott gmbh, germany.Mdr number 3002809144-2020-00032 has been submitted and all further information will be documented under that mdr number.
 
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Brand Name
ALINITY I TSH REAGENT
Type of Device
TSH
Manufacturer (Section D)
A.I.D.D LONGFORD
lisnamuck
co. longford
longford NA
EI  NA
MDR Report Key9510224
MDR Text Key219770023
Report Number3005094123-2019-00388
Device Sequence Number1
Product Code JLW
UDI-Device Identifier00380740131142
UDI-Public00380740131142
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 01/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number07P48-20
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received01/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ALINITY I PROCESSING MODULE; ALINITY I PROCESSING MODULE, LIST 03R65-01; LN 03R65-01 SN (B)(6) ; SERIAL (B)(6)
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