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

Model Number 58104

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2020

Event Type  Injury  

Manufacturer Narrative

Investigations are on going under corporate complaint (b)(4).Stago will provide a follow-up report(s) once relevant information has become available.

Event Description

On (b)(6) 2020, customer released an inr greater than 16.0 following two repeated vmax error on the pt test.According to the customer, quality control before and after the results were in range.Customer performed the maintenance of the instrument and repeated again the test: inr= 2.4.The corrected result was called to provider: no change made to patient therapy due to the initial result.Then on (b)(6) 2020, qc for pt and ptt were in vmax error.Qc repeated within range but after a third run, ptt qc were in vmax again.Instrument taken out of service and samples frozen.A technical intervention has been asked and performed the same day: the technician found a needle clogged and replaced needle from customer inventory.Preliminary conclusion: the most likely root cause was a clogged needle.

• Brand Name: STA SATELLITE
• Type of Device: IVD COAGULATION DEVICE/INSTRUMENT
• Manufacturer (Section D): DIAGNOSTICA STAGO; 2 rue pierre fossati; franconville, 95130 ; FR 95130
• Manufacturer Contact: walid ben ammar ; 2 rue pierre fossati; franconville, 95130 ; FR 95130
• MDR Report Key: 10024815
• MDR Text Key: 196464722
• Report Number: 8043723-2020-00003
• Device Sequence Number: 1
• Product Code: JPA
• UDI-Device Identifier: 03607450581041
• UDI-Public: (01)03607450581041(11)180406(241)58104
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082248
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 58104
• Date Manufacturer Received: 04/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other