MAUDE Adverse Event Report: DIAGNOSTICA STAGO STA COMPACT; IVD COAGULATION DEVICE / INSTRUMENT, PRODUCT CODE: JPA

Model Number 58612

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2019

Event Type  Injury  

Manufacturer Narrative

The analyzer produced a warning message for both erroneous results and qc was not re-run by the technician.The field support engineer was not able to reproduce the issue; however, since he found the vacuum pressure to be insufficient, he replaced the vacuum pump.Stago is still investigating this case and will provide a follow-up report when more information becomes available.

Event Description

On (b)(6) 2019 erroneous results were reported for two patients : first patient: ptt error, repeat ptt 151.7 sec, 3rd run ptt>max, 4th run ptt 68.1 sec.(on the other instrument: ptt 66.6 sec).The patient received treatment (stopped heparin drip temporarily) based on the result reported.Stago understands that no serious injury or illness resulted.Second patient: ptt error, repeat ptt 152.7 sec, 3rd run ptt>max, 4th run ptt 121 sec.(on the other instrument: ptt 132.5 sec).Stago knows of no resulting change in treatment for this patient, although the questionnaire has not been received despite 5 documented requests.References: (b)(4).

• Brand Name: STA COMPACT
• Type of Device: IVD COAGULATION DEVICE / INSTRUMENT, PRODUCT CODE: JPA
• Manufacturer (Section D): DIAGNOSTICA STAGO; 3 allée thérésa; asnières-sur-seine, 92600 ; FR 92600
• MDR Report Key: 9610237
• MDR Text Key: 189497331
• Report Number: 2245451-2020-00002
• Device Sequence Number: 1
• Product Code: JPA
• UDI-Device Identifier: 030607450586122
• UDI-Public: (01)030607450586122(11)080605(241)58612
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/20/2020,12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 58612
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/20/2020
• Distributor Facility Aware Date: 12/03/2019
• Device Age: 15 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other