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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 Negative Result (1225)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/25/2020
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 a false nonreactive architect syphilis tp result on one male patient. The following data was provided: on 25mar2020 initial sample
=
0. 04 s/co (<1. 00 s/co
=
non-reactive), the sample was repeated by domestic luminescence method which
=
1. 64 s/co and the colloidal gold testing was weakly positive. The riba testing was also negative. 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 Key9967474
MDR Text Key187939785
Report Number3002809144-2020-00328
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,Followup
Report Date 06/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/12/2020
Device Catalogue Number08D06-74
Device Lot Number07413BE01
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 Received06/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/02/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/16/2020 Patient Sequence Number: 1
Treatment
ARCHITECT I2000SR ANALYZER, LN 03M74-02,; SERIAL # (B)(4).
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