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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.
 
Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs, a review of labeling and accuracy testing.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.The product was not available for return.An internal panel was tested with retained kits of the likely cause reagent lot and accuracy testing met all specifications.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.
 
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Brand Name
ARCHITECT HE4
Type of Device
HE4
Manufacturer (Section D)
ABBOTT GERMANY
max-planck-ring 2
wiesbaden 65205
GM  65205
MDR Report Key8246625
MDR Text Key133207764
Report Number3002809144-2019-00011
Device Sequence Number1
Product Code OIU
Combination Product (y/n)N
PMA/PMN Number
K093957
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 02/04/2019
1 Device was Involved in the Event
1 Patient was 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 Health Professional
Device Expiration Date04/10/2019
Device Catalogue Number02P54-25
Device Lot Number88018M800
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARCHITECT I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74-02, SN (B)(4); LN 03M74-02, SN (B)(4)
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