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 GMBH ALINITY I SYPHILIS TP REAGENT KIT; ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
  • 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 GMBH ALINITY I SYPHILIS TP REAGENT KIT; ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM Back to Search Results
Catalog Number 07P60-32
Device Problem False Positive Result (1227)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2024
Event Type  Injury  
Event Description
The customer reported a 17 year old male patient was not eligible for a state-subsidized high-tech operation for an injured leg due to a false reactive alinity i syphilis tp result.No specific data or comparative data was provided.No further patient information was available.
 
Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 7p60-32 has a similar product distributed in the us, list number 7p60-21/-31.All available patient information was included.Additional patient details are not available.
 
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.Additionally, in-house testing was completed.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.A search for similar complaints did identify an increase in complaint activity for lot 55063be00, however, no related trends were identified regarding commonalities for complaint lot number and issue.In-house specificity testing was completed with complaint lot number 55063be00.All specifications were met, and no false reactive results were obtained, indicating that the specificity performance is not negatively impacted.Device history review did not identify any non-conformances or deviations with lot 55063be00 and the complaint issue.The overall performance of alinity i syphilis tp was reviewed using field data from customers worldwide.The number of standard deviation to cutoff for the negative population and the total population median value for lot 55063be00 is within the established limits and comparable to the historical performance.Additionally, the lot has a comparable or even lower initial reactive than historical reagent lot(s).No usual reagent performance was identified.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity i syphilis tp reagent lot 55063be00 was identified.
 
Event Description
The customer reported a 17 year old male patient was not eligible for a state-subsidized high-tech operation for an injured leg due to a false reactive alinity i syphilis tp result.No specific data or comparative data was provided.No further patient information was available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ALINITY I SYPHILIS TP REAGENT KIT
Type of Device
ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
Manufacturer (Section D)
ABBOTT GMBH
max-planck-ring 2
wiesbaden 65205
GM  65205
Manufacturer (Section G)
ABBOTT GMBH
max-planck-ring 2
wiesbaden 65205
GM   65205
Manufacturer Contact
nicole jenne
max-planck-ring 2
post market surveillance
wiesbaden 65205
GM   65205
6122582960
MDR Report Key19139620
MDR Text Key340561108
Report Number3002809144-2024-00116
Device Sequence Number1
Product Code LIP
UDI-Device Identifier00380740121655
UDI-Public(01)00380740121655(17)240727(10)55063BE00
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
K153730
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 05/09/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number07P60-32
Device Lot Number55063BE00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/08/2024
Initial Date FDA Received04/18/2024
Supplement Dates Manufacturer Received05/07/2024
Supplement Dates FDA Received05/09/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/04/2023
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)
Patient Outcome(s) Disability;
Patient Age17 YR
Patient SexMale
-
-