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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 12/09/2020
Event Type  malfunction  
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 08d06-77 that has a similar product distributed in the us, list number 8d06-31.
 
Event Description
The customer generated a false negative architect (b)(6) tp result for one patient. The following information was provided: on (b)(6) 2020 sid (b)(6) initial result 0. 49s/co, retest 0. 52s/co and 0. 53s/co; tppa positive the patient is a (b)(6) year old male being diagnosed with a rash. No impact to patient management was reported.
 
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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 Key11039600
MDR Text Key241307310
Report Number3002809144-2020-01196
Device Sequence Number1
Product Code LIP
Combination Product (y/n)N
Reporter Country CodeCH
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,Followup,Followup
Report Date 08/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/02/2021
Device Catalogue Number08D06-77
Device Lot Number12693BE01
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/18/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/10/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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