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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 reactive architect syphilis tp result when processing on the architect i1000sr. The following data was provided for the (b)(6) year old female patient: sid3001182902. Generated initial result of 10. 4s/co (>/
=
1. 00s/co
=
reactive) on 19feb2020; rpr
=
negative. Due to the false reactive syphilis results and for neurological reasons a cerebrospinal sample (csf) was taken and sent to a reference lab. The csf and the serum tested negative with vitro's rpr, tpa, and tpa chemiluminescence ocd. The customer then retested the original sample (sid18829 on 24feb2020) on architect
=
12. 64s/co / rpr
=
negative. This sample was sent to the reference lab where it tested negative. 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 Key9911574
MDR Text Key187554989
Report Number3002809144-2020-00280
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 Date09/27/2020
Device Catalogue Number08D06-32
Device Lot Number10028BE00
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 Manufactured10/16/2019
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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