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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 06/01/2020
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process. A follow-up report will be submitted when the evaluation is completed. This report is being filed on an international product, list number 08d06-29 that has a similar product distributed in the us, list number 08d06-31.
 
Event Description
The customer reported a false non-reactive architect (b)(6) tp result on a patient. The patient sample generated a result of 0. 61 s/co (non-reactive) on an architect i 1000sr analyzer. The customer recentrifuged the patient sample generating a result of 0. 60 s/co. The sample was also tested at a different facility with an abbott platform and generated results of 0. 60 s/co. The cutoff range is <1. 00 s/co (non-reactive) and >
=
1. 00 s/co (reactive). The patient sample generated a tppa result of positive. 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 Key10144104
MDR Text Key229574228
Report Number3002809144-2020-00470
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 06/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/11/2020
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 Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2020
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

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