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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 08D06-74
Device Problem False Positive Result (1227)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/24/2020
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. There was no additional patient information provided by the customer. This report is being filed on an international product, list number 8d06-74 that has a similar product distributed in the us, list number 8d06-31.
 
Event Description
The customer reported false reactive architect syphilis assay results for one patient. The customer provided the patients initial
=
1. 88 s/co, and it was still reactive after retesting (no value provided). (reference < 1. 0
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not reactive; >
=
1. 0
=
reactive). The customer stated this patients results are negative using different methodologies such as enzyme-linked immunoassay. There was no impact to patient management 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 Key10402127
MDR Text Key203897986
Report Number3002809144-2020-00817
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 09/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/19/2020
Device Catalogue Number08D06-74
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 Received09/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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