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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I FREE T4 REAGENT KIT; RADIOIMMUNOASSAY, FREE THYROXINE
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ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I FREE T4 REAGENT KIT; RADIOIMMUNOASSAY, FREE THYROXINE Back to Search Results
Catalog Number 07P70-30
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/21/2024
Event Type  malfunction  
Manufacturer Narrative
Complete information for section a1 - patient identifier: sid (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer observed imprecise alinity i free t4 results generated on alinity i processing modules for multiple samples.The following data was provided.The following results were provided: (customer provided reference range 9-19 pmol/l).Sid (b)(6) processed on (b)(6) 2024 initial result = 20.93 pmol/l processed on (b)(6) repeat = 15.38 pmol/l processed on (b)(6).Sid (b)(6) processed on (b)(6) 2024 initial result = 24.41 pmol/l (b)(6) repeat = 14.66 pmol/l (b)(6) ).Sid (b)(6) processed on (b)(6) 2024 initial result = 21.16 pmol/l (b)(6) repeat = 14.62 pmol/l (b)(6) and 15.68 pmol/l (b)(6).Sid (b)(6) processed on (b)(6) 2024 initial result = 25.61 pmol/l (b)(6) ) repeated on (b)(6) 2024 = 11.87 pmol/l (b)(6) ) and 12.66 pmol/l(b)(6).Sid (b)(6) processed on (b)(6) 2024 initial result = 25.07 pmol/l (b)(6) ) repeated on (b)(6) 2024 = 12.82 pmol/l (b)(6) no impact to patient management was reported.
 
Event Description
The customer observed imprecise alinity i free t4 results generated on alinity i processing modules for multiple samples.The following data was provided.The following results were provided: (customer provided reference range 9-19 pmol/l) sid (b)(6)processed on (b)(6)2024 initial result = 20.93 pmol/l processed on ((b)(6)) repeat = 15.38 pmol/l processed on ((b)(6)) sid (b)(6)processed on (b)(6)2024 initial result = 24.41 pmol/l ((b)(6)) repeat = 14.66 pmol/l ((b)(6)) sid (b)(6)processed on (b)(6)2024 initial result = 21.16 pmol/l ((b)(6)) repeat = 14.62 pmol/l (ai01867) and 15.68 pmol/l ((b)(6)) sid (b)(6)processed on (b)(6)2024 initial result = 25.61 pmol/l ((b)(6)) repeated on (b)(6)2024 = 11.87 pmol/l ((b)(6)) and 12.66 pmol/l((b)(6)) sid (b)(6)processed on (b)(6)2024 initial result = 25.07 pmol/l ((b)(6)) repeated on (b)(6)2024 = 12.82 pmol/l ((b)(6)) no impact to patient management was reported.
 
Manufacturer Narrative
B.Adverse event or product problem b3 - date of event corrected to(b)(6)2024.
 
Manufacturer Narrative
Complete information for section a1 - patient identifier: sid (b)(6) and updated patient information sid (b)(6).Patient data added 26mar2024 updated section b.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This incident was also submitted for alinity i free t4(07p70-30) lot 56159ud00, see related manufacturer report number 3005094123-2024-00155-00.
 
Event Description
The customer observed imprecise alinity i free t4 results generated on alinity i processing modules for multiple samples.The following data was provided.The following results were provided: (customer provided reference range 9-19 pmol/l).Sid (b)(6) processed on (b)(6) 2024 initial result = 20.93 pmol/l processed on (b)(6) repeat = 15.38 pmol/l processed on (b)(6).Sid (b)(6) processed on (b)(6) 2024 initial result = 24.41 pmol/l (b)(6) repeat = 14.66 pmol/l (b)(6).Sid (b)(6) processed on (b)(6) 2024 initial result = 21.16 pmol/l (b)(6) repeat = 14.62 pmol/l (b)(6) and 15.68 pmol/l (b)(6).Sid (b)(6) processed on (b)(6) 2024 initial result = 25.61 pmol/l (b)(6) repeated on (b)(6) 2024 = 11.87 pmol/l (b)(6) and 12.66 pmol/l(b)(6).Sid (b)(6) processed on (b)(6) 2024 initial result = 25.07 pmol/l (b)(6) repeated on (b)(6) 2024 = 12.82 pmol/l (b)(6).Additional data added 26mar2024: sid (b)(6) initial result = 19.55 pmol/l repeat result = 10.26 pmol/l(b)(6).Sid (b)(6) initial result = 23.72 pmol/l repeat result = 12.95 pmol/l(b)(6).Sid (b)(6) initial result = 28.95 pmol/l repeat result = 14.08 pmol/l(b)(6).Sid (b)(6) initial result = 56.22 pmol/l repeat result = 13.08 pmol/l(b)(6).Sid (b)(6) initial result = 23.54 pmol/l repeat result = 13.31 pmol/l(b)(6).Sid (b)(6) initial result = 28.92 pmol/l(b)(6) repeat result = 18.90 pmol/l(b)(6) no impact to patient management was reported.
 
Manufacturer Narrative
Complete information for section a1 - patient identifier: sid (b)(6), and updated patient information sid (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This incident was also submitted for alinity i free t4(07p70-30) lot 56159ud00, see related manufacturer report number 3005094123-2024-00155-00.
 
Event Description
The customer observed imprecise alinity i free t4 results generated on alinity i processing modules for multiple samples.The following data was provided.The following results were provided: (customer provided reference range 9-19 pmol/l).Sid (b)(6) processed on (b)(6) 2024 initial result = 20.93 pmol/l processed on ((b)(6)) repeat = 15.38 pmol/l processed on ((b)(6)) sid (b)(6) processed on (b)(6) 2024 initial result = 24.41 pmol/l ((b)(6)) repeat = 14.66 pmol/l ((b)(6)) sid (b)(6) processed on (b)(6) 2024 initial result = 21.16 pmol/l ((b)(6)) repeat = 14.62 pmol/l ((b)(6)) and 15.68 pmol/l ((b)(6)) sid (b)(6)processed on (b)(6) 2024 initial result = 25.61 pmol/l ((b)(6)) repeated on (b)(6) 2024 = 11.87 pmol/l ((b)(6)) and 12.66 pmol/l ((b)(6)) sid (b)(6) processed on (b)(6) 2024 initial result = 25.07 pmol/l ((b)(6)) repeated on (b)(6) 2024 = 12.82 pmol/l ((b)(6)) additional data added 26mar2024: sid (b)(6) initial result = 19.55 pmol/l repeat result = 10.26 pmol/l((b)(6) ) sid (b)(6) initial result = 23.72 pmol/l repeat result = 12.95 pmol/l((b)(6) ) sid (b)(6) initial result = 28.95 pmol/l repeat result = 14.08 pmol/l((b)(6) ) sid (b)(6) initial result = 56.22 pmol/l repeat result = 13.08 pmol/l((b)(6) ) sid (b)(6) initial result = 23.54 pmol/l repeat result = 13.31 pmol/l((b)(6) ) sid (b)(6) initial result = 28.92 pmol/l((b)(6) ) repeat result = 18.90 pmol/l((b)(6) ) no impact to patient management was reported.
 
Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, and labeling review.Additionally, in-house testing was performed.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.An increase in complaints has been observed for lot 57607ud00, however, in-house performance testing was completed which indicates the product is performing as expected.The device history record review did not identify any nonconformances, potential nonconformances or deviations associated with lot number 57607ud00 and the complaint issue.Labeling was reviewed and adequately addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity i free t4 for lot 57607ud00 was identified.
 
Event Description
The customer observed imprecise alinity i free t4 results generated on alinity i processing modules for multiple samples.The following data was provided.The following results were provided: (customer provided reference range 9-19 pmol/l) sid (b)(6) processed on 27feb2024 initial result = 20.93 pmol/l processed on (b)(6) repeat = 15.38 pmol/l processed on (b)(6) sid (b)(6) processed on 22feb2024 initial result = 24.41 pmol/l ((b)(6) repeat = 14.66 pmol/l (b)(6) sid (b)(6) processed on 21feb2024 initial result = 21.16 pmol/l (b)(6) repeat = 14.62 pmol/l ((b)(6) and 15.68 pmol/l (b)(6) sid (b)(6) processed on 21feb2024 initial result = 25.61 pmol/l ((b)(6) repeated on 22feb2024 = 11.87 pmol/l ((b)(6) and 12.66 pmol/l (b)(6) sid (b)(6) processed on (b)(6) 2024 initial result = 25.07 pmol/l ((b)(6) repeated on 27feb2024 = 12.82 pmol/l ((b)(6) additional data added 26mar2024: sid (b)(6) initial result = 19.55 pmol/l repeat result = 10.26 pmol/l (b)(6) sid (b)(6) initial result = 23.72 pmol/l repeat result = 12.95 pmol/ln(b)(6) sid (b)(6) initial result = 28.95 pmol/l repeat result = 14.08 pmol/l(b)(6) sid (b)(6) initial result = 56.22 pmol/l repeat result = 13.08 pmol/l(b)(6) sid (b)(6) initial result = 23.54 pmol/l repeat result = 13.31 pmol/l (b)(6) sid (b)(6) initial result = 28.92 pmol/l(ai01867) repeat result = 18.90 pmol/l(b)(6) no impact to patient management was reported.
 
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Brand Name
ALINITY I FREE T4 REAGENT KIT
Type of Device
RADIOIMMUNOASSAY, FREE THYROXINE
Manufacturer (Section D)
ABBOTT IRELAND DIAGNOSTICS DIVISION
lisnamuck
co. longford
longford N39E9 32
EI  N39E932
Manufacturer (Section G)
ABBOTT IRELAND DIAGNOSTICS DIVISION
lisnamuck
co. longford
longford N39E9 32
EI   N39E932
Manufacturer Contact
nicole jenne
max-planck-ring 2
post market surveillance
wiesbaden 65205
GM   65205
6122582960
MDR Report Key18897713
MDR Text Key337673660
Report Number3005094123-2024-00119
Device Sequence Number1
Product Code CEC
UDI-Device Identifier00380740121822
UDI-Public00380740121822
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K173122
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,Followup
Report Date 04/09/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number07P70-30
Device Lot Number57607UD00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/26/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/28/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
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