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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I TOTAL B-HCG REAGENT KIT; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
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ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I TOTAL B-HCG REAGENT KIT; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN Back to Search Results
Catalog Number 07P51-20
Device Problem False Negative Result (1225)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2023
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 observed falsely depressed alinity i total b-hcg results for one patient.The following data was provided: first collection (b)(6) 2023 sid (b)(6) initial result 139.40 mlu/ml (positive).Second collection (b)(6) 2023 sid (b)(6) initial result 2019.25 mlu/ml (positive), repeated 2082.92 mlu/ml (positive) and < 2.30 mlu/ml (negative).Third collection (b)(6) 2023 sid (b)(6) initial result 2085.77 mlu/ml (positive), repeated 2131.61 and 2164.15 mlu/ml (positive).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, labeling review, device history record review, and field data review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.The ticket search by lot indicates that the complaint lot performs as expected for this product.Ticket trending review did not identify any trends.Device history review did not identify any non-conformances or deviations with the complaint lot.The overall performance of the alinity i total b-hcg reagents in the field was reviewed using data gathered from customers worldwide.The median value of the negative population for the complaint lot 54180ud00 is within established limits and thus comparable to the historical lot performance, which confirms no systemic issue for the lot.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity i total b-hcg reagent lot 54180ud00 was identified.
 
Event Description
The customer observed falsely depressed alinity i total b-hcg results for one patient.The following data was provided: first collection (b)(6) 2023 sid (b)(6) initial result 139.40 mlu/ml (positive).Second collection (b)(6) 2023 sid (b)(6) initial result 2019.25 mlu/ml (positive), repeated 2082.92 mlu/ml (positive) and < 2.30 mlu/ml (negative).Third collection (b)(6) 2023 sid (b)(6) initial result 2085.77 mlu/ml (positive), repeated 2131.61 and 2164.15 mlu/ml (positive).No impact to patient management was reported.
 
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Brand Name
ALINITY I TOTAL B-HCG REAGENT KIT
Type of Device
SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
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 Key18468615
MDR Text Key332727532
Report Number3005094123-2024-00014
Device Sequence Number1
Product Code DHA
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K170317
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 Received01/08/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number07P51-20
Device Lot Number54180UD00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/21/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/10/2023
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)
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