MAUDE Adverse Event Report: DIAGNOSTICA STAGO S.A.S. STA-R MAX; IVD COAGULATION DEVICE/INSTRUMENT

Model Number 59010

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

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

Event Date 03/06/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On 18apr2019: the customer contacted the (b)(6) hotline and asked if the issue with the inr could be attributed to a setting.The customer was informed that their stago technical support specialist (tss) would contact them.The stago tss went to the customer site and found that they had entered an incorrect geometric mean of 11.2 instead of their recorded value of 13.1.The tss was able to correct the entry to the proper value.On 22apr2019: a stago field support engineer arrived to review the system performance.The instrument in question was in use by the customer when he arrived.All checks were within stago specifications.Per customer no patient results affected since last call into hotline.System performance was verified by the fse and the instrument was performing within stago specifications.On 30apr2019: the customer did not return any requested documentation, so it cannot be determined if they took any action.They requested the (b)(6) hotline to follow up and determine exactly when the issue started.On 06may2019: stago was notified by the customer that approximately 800 results were suspect.On 10may2019: although the issue appears to be customer related, given the amount of impacted patients (~800) the manufacturer decided to report the event.Investigations are still on going.Stago will provide a follow-up report(s) once relevant information has become available.

Event Description

On 17apr2019: a customer contacted the (b)(6) hotline ((b)(6)) regarding an incorrect inr that was reported in the month of (b)(6) 2019.Original result: (b)(6) 2019: pt=16.1 sec, inr=1.60.Corrected result: (b)(6) 2019: pt=16.1 sec, inr=1.31.The patient attending physician contacted the lab director and questioned the result.The lab director contacted the lab and verified - with lis system as well - the reported result.A screen shot of the report was sent and it was suggested not to use the instrument until stago service evaluates the system.The customer was unable to pull the results from the instrument; they may have deleted the patient files.The customer stated that they do not have any data for the month of (b)(6).The customer utilizes a single lot per year, and this lot was a new lot - sta neoplastine ci plus 10ml # 253730, isi=1.30, geo mean=13.1.The inr was recalculated based upon this information and the corrected result was reported on (b)(6) 2019.The lab's back-up analyzer has the correct geo mean and isi.The impact to this patient was unknown.

Manufacturer Narrative

Diagnostica stago, inc.Is submitting this report on behalf of diagnostica stago s.A.S.Gennevilliers (manufacturer) under exemption number e2012018.Investigations / identification of causes: the analysis of the instrument files shows that the lot of sta -néoplastine ci plus previously used by the customer was 251800 (isi = 1.28) until 23jan2019.According to the information received, this lot had the same geometric mean time (13.1 seconds) as the next one (253730).Lot 253730 concerned with the issue (isi = 1.30) was used for the first time on this instrument on 16nov2018, 22nov2018 and 23nov2018 to prepare for the lot conversion.The final change from lot 251800 to lot 253730 took place on 23jan2019 around 4am.From this date until the discovery of the issue on 17apr2019, there were 12,274 patient pt results including about 800 inr results according to the laboratory (the only ones likely to be impacted by the problem).Since the instrument files do not contain the value of the geometric mean time nor the date on which it was recorded in the instrument, stago must assume that the problem began on 23jan2019 when the lots were changed.The study of the evolution of the inr results could have made it possible to estimate the date of the change, but the instrument files only contain the raw results in time.It is important to note that the laboratory's back-up instrument (sta r max no.0765) had the correct value of the geometric mean.It therefore seems to be an operator error when initially logging in the mean normal prothrombin time into sta r max no.0751, or a subsequent erroneous modification.The client was asked to provide stago with their conclusions regarding the investigations of the ~800 results impacted, and the possible consequences for the health of the patients concerned.To date, despite several reminders from dsi, the customer did not provide the requested information.Corrective actions proposed / carried out following the analysis of the causes: other than the correction of the geometric mean by a stago tss on 18apr2019 no other corrective action will be put in place following the analysis of this claim since the most likely root cause is an isolated operator error.Status of the complaint: stago has concluded its investigation into this matter.

Manufacturer Narrative

Diagnostica stago, inc.Is submitting this report on behalf of diagnostica stago s.A.S.Gennevilliers (manufacturer) under exemption number e2012018.The prior reports' mfr.Numbers were submitted in erratum.The correct mfr.# is 8043723-2019-00005.

• Brand Name: STA-R MAX
• Type of Device: IVD COAGULATION DEVICE/INSTRUMENT
• Manufacturer (Section D): DIAGNOSTICA STAGO S.A.S.; 3 allée theresa; asnières-sur-seine, 92600 ; FR 92600
• MDR Report Key: 8607618
• MDR Text Key: 152058400
• Report Number: 8043273-2019-00005
• Device Sequence Number: 1
• Product Code: JPA
• Combination Product (y/n): N
• PMA/PMN Number: K151867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2019,04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 59010
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/17/2019
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2019
• Date Manufacturer Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1