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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT SYPHILIS TP

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ABBOTT GMBH ARCHITECT SYPHILIS TP 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 05/28/2020
Event Type  malfunction  
Manufacturer Narrative
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 8d06-77 that has a similar product distributed in the us, list number 8d06-41.
 
Event Description
The customer reported a (b)(6) architect syphilis tp result on a (b)(6)-yr old female patient. Results provided: (b)(6) 2020, sid (b)(6)
=
(b)(6), repeated on another architect under sid (b)(6)
=
(b)(6); cmia and rpr
=
(b)(6), tpaa
=
(b)(6). Previous testing with chemiluminescence and tpaa were (b)(6). No impact to patient management was reported.
 
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Brand NameARCHITECT SYPHILIS TP
Type of DeviceSYPHILIS
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, bldg cp01-3
abbott park, IL 60064-3537
224668-294
MDR Report Key10119630
MDR Text Key204456547
Report Number3002809144-2020-00433
Device Sequence Number1
Product Code LIP
Combination Product (y/n)N
Reporter Country CodeCH
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 07/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/19/2020
Device Catalogue Number08D06-77
Device Lot Number08519BE01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/13/2019
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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