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

Model Number 58989

Device Problem Low Test Results (2458)

Patient Problem Insufficient Information (4580)

Event Date 01/29/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, the instrument produced critical heparin (ufh) results for 4 patients :ufh = 0.00 ui/ml.When samples were reran, the results were as follow: a.Initial result: <0.10, corrected: 0.49 drawn date/time: original: (b)(6) 2023 @ 06:31 corrected: 10:00; b.Initial result: <0.10, corrected: 0.82 drawn date/time: original: (b)(6) 2023 @ 06:05 corrected: 09:29; c.Initial result: <0.10, corrected: 0.17 drawn date/time: original: (b)(6) 2023 @ 07:22 corrected: 09:36; d.Initial result: <0.10, corrected: 0.68 drawn date/time: original: (b)(6) 2023 @ 07:22 corrected: 09:39.Samples were uncapped.According to the customer, results have been released, and patient(s) received treatment or had treatment withheld based on the results reported.Diagnostica stago has received no details of treatment(s) changes.No serious injuries or deaths have been reported.

Manufacturer Narrative

On 2023-01-29, the customer called the hotline to report and explain the event.On 2023-01-30, a service engineer (fse) was dispatched to the customer.No instrument problem was identified (the service engineer (fse) ran qc and precision for pt, ptt, fib, ddi, and hep assays.All results were in range).On (b)(6) 2023, the customer called the hotline to report that the instrument produced 3 other critical heparin (ufh) results ufh = 0.00 ui/ml.When samples were reran, the results were as follow: pid (b)(6) => initial result was 0.0 ((b)(6) 2023 7:09) ran on another unit ((b)(4)) and resulted 0.31 ((b)(6) 2023 7:25); pid (b)(6) => initial result was 0.00 ((b)(6) 2023 7:11) ran on other unit ((b)(4)) and resulted 0.30 ((b)(6) 2023 07:38); pid (b)(6) => initial result was 0.0 ((b)(6) 2023 7:09) reran on other unit ((b)(4)) and resulted 0.45 ((b)(6) 2023 7:24).Samples were capped.According to the customer, results haven't been released.On 2023-02-10, an fse was dispatched to the customer.No instrument problems were identified (verification of needle volumes, washing wells vacuum, and temperatures.All were in range.Fse ran qc and precision for pt, ptt, ddi, fib, and hep & patient samples.All were in range).The instrument data files were collected.Investigation is on-going.Diagnostica stago will provide a follow-up report once more relevant information is available.

• Brand Name: STA COMPACT MAX
• Type of Device: IVD COAGULATION DEVICE/INSTRUMENT
• Manufacturer (Section D): DIAGNOSTICA STAGO; 2 rue pierre fossati; franconville, 95 95130 ; FR 95130
• Manufacturer Contact: walid ben ammar ; 2 rue pierre fossati; franconville, 95 95130 ; FR 95130
• MDR Report Key: 16443703
• MDR Text Key: 310434719
• Report Number: 8043723-2023-00001
• Device Sequence Number: 1
• Product Code: JPA
• UDI-Device Identifier: 03607450589894
• UDI-Public: (01)03607450589894(11)170519(241)58989
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 58989
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other