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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DIAGNOSTICA STAGO STA-R EVOLUTION; IVD COAGULATION DEVICE / INSTRUMENT
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DIAGNOSTICA STAGO STA-R EVOLUTION; IVD COAGULATION DEVICE / INSTRUMENT Back to Search Results
Model Number 58978
Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/16/2019
Event Type  Injury  
Manufacturer Narrative
There was poor vacuum at wash wells.The vacuum diaphragm was repaired.Investigations are still on going.
 
Event Description
On (b)(6) 2019, the customer reported six erroneous ptt results had been produced and released.Qc results were within range before and after the erroneous results were produced.The customer later indicated (questionnaire dated (b)(6) 2019) that there were five patients involved, and stated that there were no life-threatening or permanent effects on the patients.At least one of the patients did receive heparin therapy based on the erroneous results.Corporate complaint file: (b)(4).Importer complaint file: (b)(4).
 
Manufacturer Narrative
The field support engineer reseated the vacuum diaphragm due to a reduced vacuum measured at wash wells; it was not replaced.The fse then verified the valcor pump volume and remapped the needles to the wash wells, shuttle, and measurement plate.The dump files were analyzed and the following were determined: qc was in range before and after the sample, therefore the reduced vacuum was not detected.No alarm or alarm codes were produced.No issue with sample detection or reagent detection was discovered.It is not possible to detect the reduced vacuum in the dump files.The preliminary root cause has since been ruled out.If the root cause had been a failed diaphragm, it is very likely that the qc would have been affected and the erroneous results would have been more widespread.The engineer did inspect the pump diaphragm which was partially unseated but not damaged.The intermittent issue, where 5 patients experienced erroneous ptt results at different times in the same day, and not within the same run, is more consistent with a partially unseated diaphragm.Based upon the investigation, a true root cause could not be definitively determined.Stago has concluded its investigation into this matter and considers it as confirmed and isolated, with no further action.
 
Event Description
On (b)(6) 2019, the customer reported six erroneous ptt results had been produced and released.Qc results were within range before and after the erroneous results were produced.The customer later indicated (questionnaire dated (b)(6) 2019) that there were five patients involved, and stated that there were no life-threatening or permanent effects on the patients.At least one of the patients did receive heparin therapy based on the erroneous results.Corporate complaint file: (b)(4).Importer complaint file: (b)(4).
 
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Brand Name
STA-R EVOLUTION
Type of Device
IVD COAGULATION DEVICE / INSTRUMENT
Manufacturer (Section D)
DIAGNOSTICA STAGO
3 allée thérésa
asnières sur seine, 92600
FR  92600
MDR Report Key9595990
MDR Text Key175246732
Report Number2245451-2020-00001
Device Sequence Number1
Product Code JPA
UDI-Device Identifier03607450589788
UDI-Public(01)03607450589788(11)140312(241)58978
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 01/16/2020,12/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number58978
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/16/2020
Distributor Facility Aware Date12/17/2019
Device Age6 YR
Event Location Hospital
Date Report to Manufacturer01/16/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/16/2020
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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