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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 08D06-32
Device Problem False Positive Result (1227)
Patient Problem No Code Available (3191)
Event Date 02/19/2020
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 8d06-32 that has a similar product distributed in the us, list number 8d06-31. All patient information provided has been included in this report.
 
Event Description
The customer observed a false (b)(6) architect (b)(6) tp result when processing on the architect i1000sr. The following data was provided for the (b)(6) year old female patient: (b)(6). Generated initial result of (b)(6) on (b)(6) 2020; (b)(6). Due to the false (b)(6) results and for neurological reasons a cerebrospinal sample (csf) was taken and sent to a reference lab. The csf and the serum tested (b)(6) with vitros rpr, tppa, and tpa chemiluminesence ocd. The customer then retested the original sample ((b)(6) on (b)(6) 2020) on architect
=
(b)(6). This sample was sent to the reference lab where it tested (b)(6). Patient was evaluated at a day clinic for cognitive deficit. Tests included imaging and blood. Imaging report indicated moderately to severely decreased perfusion parietotemporal (re> li) and more limited hippocampal (re> li). Mesial temporal atrophy (mta) grade 2. Also determination of biological markers on lumbar fluid for the diagnosis of alzheimer's. The results of this are indicative of underlying amyloid pathology.
 
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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 Key9911522
MDR Text Key187551388
Report Number3002809144-2020-00279
Device Sequence Number1
Product Code LIP
Combination Product (y/n)N
Reporter Country CodeBE
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 06/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/13/2020
Device Catalogue Number08D06-32
Device Lot Number11036BE00
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 Manufactured12/12/2019
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: 04/01/2020 Patient Sequence Number: 1
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