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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. APTIO AUTOMATION
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SIEMENS HEALTHCARE DIAGNOSTICS INC. APTIO AUTOMATION Back to Search Results
Model Number APTIO AUTOMATION
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/08/2021
Event Type  malfunction  
Manufacturer Narrative
Siemens investigated an internal complaint for the aptio automation interface module to the advia centaur xp/xpt analyzers.When a sample tube that is to be processed by the advia centaur xp/xpt is not diverted into the interface module due to a mechanical issue or due to an obstruction, one of the following sample tube(s) that is diverted into the interface module to be processed by the advia centaur xp/xpt may be released from the interface module, flagged with the error code 3160 "sampling not successful" and with test results obtained from another sample tube.There are no known reports of patient intervention or adverse health consequences due to this issue.An urgent medical device correction (umdc) lasw21-01.A.Us was sent to unites states customers and an urgent field safety notice (ufsn) lasw21-01.A.Ous was sent to outside the us (ous) customers in october of 2021.The umdc and ufsn explain the behavior described above and requests customers to follow the instructions of the umdc/ufsn to ensure correct operation of the systems.The umdc and ufsn delineate that a new version of firmware for the aptio automation interface module to the advia centaur xp/xpt system will correct the issue.
 
Event Description
Siemens investigated an internal complaint for the aptio automation interface module to the advia centaur xp/xpt analyzers.When a sample tube that is to be processed by the advia centaur xp/xpt is not diverted into the interface module due to a mechanical issue or due to an obstruction, one of the following sample tube(s) that is diverted into the interface module to be processed by the advia centaur xp/xpt may be released from the interface module, flagged with the error code 3160 "sampling not successful" and with test results obtained from another sample tube.There are no known reports of patient intervention or adverse health consequences due to this issue.
 
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Brand Name
APTIO AUTOMATION
Type of Device
APTIO AUTOMATION
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
500 gbc drive
po box 6101
newark DE 19714 6101
MDR Report Key12598208
MDR Text Key283964699
Report Number2517506-2021-00278
Device Sequence Number1
Product Code LXG
UDI-Device Identifier00630414596754
UDI-Public00630414596754
Combination Product (y/n)N
PMA/PMN Number
K043546
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Recall
Type of Report Initial
Report Date 10/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAPTIO AUTOMATION
Device Catalogue Number10713760
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/28/2021
Initial Date FDA Received10/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction Number2517506-10/08/2021-002-C
Patient Sequence Number1
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