MAUDE Adverse Event Report: DIAGNOSTICA STAGO STA COMPACT MAX; IVD COAGULATION DEVICE / INSTRUMENT

Model Number 58989

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Aortic Dissection (2491); Thromboembolism (2654)

Event Date 12/01/2019

Event Type  Death  

Event Description

The patient experienced a type 1 aortic dissection.The technician manually released a ddi result to the lis as > 0.5 g/ml whereas the ddi was > 20.0 g/ml on the expert module (middleware).The > 0.5 g/ml result was interpreted as probably an acute thromboembolic event and the patient received a heparin drip within 24 hours of death.(b)(4).

Manufacturer Narrative

An analysis of the instrument data files shows that : the patient result on the instrument was > 20 g/ml.The quality control results before and after the result in question were within the stago the customer ranges.No problems with the analyzer occurred during the patient test.We have reviewed the event with the customer; she confirmed that it was a human error on the part of the technician, as manual reporting of the > 0.5 g/ml is a violation of their procedures.The customer took corrective actions, reviewed their policies and procedures and perform internal re-training.The stago system was not at fault in this case.Stago has completed its investigation into this matter.Stago reference number (b)(4).

Event Description

The patient experienced a type 1 aortic dissection.The technician manually released a ddi result to the lis as > 0.5 g/ml whereas the ddi was > 20.0 g/ml on the expert module (middleware).The > 0.5 g/ml result was interpreted as probably an acute thromboembolic event and the patient received a heparin drip within 24 hours of death.Manufacturer complaint file: (b)(4); importer complaint file: (b)(4).

Event Description

The patient experienced a type 1 aortic dissection.The technician manually released a ddi result to the lis as > 0.5 ug/ml whereas the ddi was > 20.0 ug/ml on the expert module (middleware).The > 0.5 ug/ml result was interpreted as probably an acute thromboembolic event and the patient received a heparin drip within 24 hours of death.Manufacturer complaint file: (b)(4).Importer complaint file: (b)(4).

• Brand Name: STA COMPACT MAX
• Type of Device: IVD COAGULATION DEVICE / INSTRUMENT
• Manufacturer (Section D): DIAGNOSTICA STAGO; 3 allée thérésa; asnières sur seine, 92600 ; FR 92600
• MDR Report Key: 9521868
• MDR Text Key: 172806455
• Report Number: 2245451-2019-00010
• Device Sequence Number: 1
• Product Code: JPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2019,12/23/2019

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 Number: 58989
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/20/2019
• Distributor Facility Aware Date: 12/03/2019
• Device Age: 4 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/17/2020; 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 70 YR