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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GERMANY ARCHITECT HE4

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ABBOTT GERMANY ARCHITECT HE4 Back to Search Results
Catalog Number 02P54-25
Device Problem False Negative Result (1225)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
All available patient information was included. Additional patient details are not available. An evaluation is in process. A final report will be submitted when the evaluation is complete.
 
Event Description
The customer observed falsely depressed he-4 results on the architect i2000sr analyzer. The following data was provided: initial 0. 00, repeat 42. 8pmol/l. There was no impact to patient management reported.
 
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Brand NameARCHITECT HE4
Type of DeviceHE4
Manufacturer (Section D)
ABBOTT GERMANY
max-planck-ring 2
wiesbaden 65205
GM 65205
Manufacturer (Section G)
ABBOTT GERMANY
max-planck-ring 2
wiesbaden 65205
GM 65205
Manufacturer Contact
noemi romero-kondos, rn bsn
100 abbott park road
dept. 09b9, lccp1-3
abbott park, IL 60064-3537
224667-512
MDR Report Key8246625
MDR Text Key133207764
Report Number3002809144-2019-00011
Device Sequence Number1
Product Code OIU
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K093957
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 02/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/10/2019
Device Catalogue Number02P54-25
Device Lot Number88018M800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2018
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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