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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT SYPHILIS TP REAGENT KIT ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM

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ABBOTT GMBH ARCHITECT SYPHILIS TP REAGENT KIT ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM Back to Search Results
Catalog Number 08D06-77
Device Problem False Positive Result (1227)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/10/2020
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. No further patient information is available. This report is being filed on an international product, list number 08d06-77 that has a similar product distributed in the us, list number 8d06-31.
 
Event Description
The customer generated falsely positive architect (b)(6) tp results for one patient. The following data was provided: sid (b)(6) initial result 4. 15 s/co, repeat 4. 24 and 4. 40 s/co. The patient is a (b)(6) old female with liver dysfunction and is rpr negative. The parents have indicated no history of syphilis, and the mother tested negative for syphilis antibodies. No impact to patient management was reported.
 
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Brand NameARCHITECT SYPHILIS TP REAGENT KIT
Type of DeviceENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
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, lc cp01-3
abbott park, IL 60064-3537
2246682940
MDR Report Key11040709
MDR Text Key241307320
Report Number3002809144-2020-01197
Device Sequence Number1
Product Code LIP
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K153730
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 01/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/02/2021
Device Catalogue Number08D06-77
Device Lot Number12693BE01
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 Received12/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/10/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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