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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT SYPHILIS TP REAGENT KIT ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM

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ABBOTT GMBH ARCHITECT SYPHILIS TP REAGENT KIT ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM Back to Search Results
Catalog Number 08D06-77
Device Problem False Negative Result (1225)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/11/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6). An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. All available patient information was included. Additional patient details are not available. This report is being filed on an international product, list number 08d06-77 that has a similar product distributed in the us, list number 08d06-31/41.
 
Event Description
The customer observed (b)(6) architect (b)(6) results on one (b)(6) female patient diagnosed with hyperthyroidism. The results provided were: on (b)(6) 2021 sid (b)(6) initial (b)(6). Roche electrochemiluminescence method at another hospital
=
(b)(6) /colloidal gold and boson chemiluminescence method
=
(b)(6)/ (b)(6) 2020 euroimmun western blotting igm
=
(b)(6) there was no reported impact to patient management.
 
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Brand NameARCHITECT SYPHILIS TP REAGENT KIT
Type of DeviceENZYME 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
christian lee
100 abbott park road
dept. 09b9, lc cp01-3
abbott park, IL 60064-3537
2246682940
MDR Report Key11230298
MDR Text Key244470950
Report Number3002809144-2021-00056
Device Sequence Number1
Product Code LIP
Combination Product (y/n)N
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,Followup
Report Date 06/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/21/2021
Device Catalogue Number08D06-77
Device Lot Number21298BE01
Was Device Available for Evaluation? No
Date Returned to Manufacturer01/22/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/19/2020
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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