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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 08D06-74
Device Problem False Negative Result (1225)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/16/2022
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer observed false nonreactive architect syphilis tp results that repeated positive on elisa for two cases. The following data was provided: 26-year-old male patient with a diagnosis of trauma; sid 1 architect syphilis tp initial result was 0. 85 s/co, repeated 0. 91 s/co, elisa positive, tppa positive. 34-year-old male patient with a diagnosis of fracture; sid 2 architect syphilis tp initial result was 0. 28 s/co, repeated 0. 22 / 0. 24 / 0. 25 s/co, elisa positive, tppa positive. 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
siobhan wright
lisnamuck
post market surveillance
longford N39 E-932
EI   N39 E932
433331157
MDR Report Key14642651
MDR Text Key294658600
Report Number3002809144-2022-00192
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 08/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/02/2022
Device Catalogue Number08D06-74
Device Lot Number30370BE01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/26/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/09/2022 Patient Sequence Number: 1
Treatment
ARC I2000SR INST, 03M74-02, ISR61418
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