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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT AUTOMATION SOLUTIONS GMBH GLP TRACK END; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
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ABBOTT AUTOMATION SOLUTIONS GMBH GLP TRACK END; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE Back to Search Results
Catalog Number 06Q42-01
Device Problem Smoking (1585)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/05/2023
Event Type  malfunction  
Event Description
The customer reported an issue with the glp track end.Specifically, smoke was seen coming out of the sample access line (sal) generic fuse after turning it on once it was installed.There was no reported impact to patient management and no reported injuries.
 
Manufacturer Narrative
This report is being filed on an international product, list number 06q42-01 and there is a similar product distributed in the us, list number 04z96-51.All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer reported an issue with the glp track end.Specifically, smoke was seen coming out of the sample access line (sal) generic fuse after turning it on once it was installed.There was no reported impact to patient management and no reported injuries.Update: additional information received (b)(6) 2023: it was reported that after the 440v was connected on the filter, the segment controllers were turned on in order to be programmed since this was a new installation.As soon as the switches on the segment controllers were turned on, smoke came out of them.The power was then shut down.It was reported that the pins on neutral line of the plugs on the bus bar was damaged.
 
Manufacturer Narrative
The field service representative (fsr) indicated that during installation of the sample access line (sal) module to the glp track, serial (b)(6), the sal generic fuse overheated after being turned on.Once connected and ready, the fsr turned on the module controller board and identified smoke coming out.Further investigation found that the pins for the neutral line of the plugs for the bus bar was damaged.The fsr replaced the module controller board to resolve the issue.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Complaint review related to the customer reported event for the module controller board did not identify any other complaints.A review of tracking and trending did not identify any trends.Review of the manufacturing documentation did not identify any non-conformances or potential non-conformances related to the module controller board.A labeling review determined product labeling addresses customer reported issue.Based on the available information, no systemic issue or deficiency was identified for the glp track end, serial number (b)(6)or module controller board.
 
Manufacturer Narrative
Section b5 has been updated with additional information.
 
Event Description
The customer reported an issue with the glp track end.Specifically, smoke was seen coming out of the sample access line (sal) generic fuse after turning it on once it was installed.There was no reported impact to patient management and no reported injuries.Update: additional information received 12 oct 2023: it was reported that after the 440v was connected on the filter, the segment controllers were turned on in order to be programmed since this was a new installation.As soon as the switches on the segment controllers were turned on, smoke came out of them.The power was then shut down.It was reported that the pins on neutral line of the plugs on the bus bar was damaged.
 
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Brand Name
GLP TRACK END
Type of Device
CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
Manufacturer (Section D)
ABBOTT AUTOMATION SOLUTIONS GMBH
sachsenkamp 5
hamburg 20097
GM  20097
Manufacturer (Section G)
ABBOTT AUTOMATION SOLUTIONS GMBH
sachsenkamp 5
hamburg 20097
GM   20097
Manufacturer Contact
nicole jenne
max-planck-ring 2
post market surveillance
wiesbaden 65205
GM   65205
6122582960
MDR Report Key17928278
MDR Text Key325565155
Report Number3023268435-2023-00036
Device Sequence Number1
Product Code JQP
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K213486
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,Followup
Report Date 12/18/2023
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 Catalogue Number06Q42-01
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/12/2023
Initial Date FDA Received10/12/2023
Supplement Dates Manufacturer Received10/12/2023
12/05/2023
Supplement Dates FDA Received10/13/2023
12/18/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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