MAUDE Adverse Event Report: GRIFOLS DIAGNOSTIC SOLUTIONS INC. PROCLEIX NAT TRACKER; BLOOD ESTABLISHMENT COMPUTER SOFTWARE

Model Number SOFTWARE V3.0

Device Problem Data Problem (3196)

Patient Problem Not Applicable (3189)

Event Date 01/18/2018

Event Type  malfunction  

Manufacturer Narrative

The original pool results were nonreactive for all of the samples.This issue was escalated to (b)(4) (nat tracker cmo).Both grifols and (b)(4) investigated the anomaly.The investigation included database simulations, review of the audit trail, error log, run report, and nat tracker software code.A network connectivity error occurred shortly before the incident.The assignment of reactive to the 17 samples occurred over a two second time period.The anomaly occurred prior to the transfer of the results to the customer lis.The assignment of reactive to a sample would only occur if an individual donor test (idt) or a manual change in the software had been performed.Review of the data from the procleix tigris instrument showed no idt samples and no reactive pools in the run.Review of the software audit trail showed no evidence of a manual data change.Neither grifols software engineering nor (b)(4) were able to duplicate the event on the nat tracker software.At the customer site, the grifols field service engineer and the customer were also unable to reproduce the results.The investigation could not determine a common link or scenario that would result in this anomaly.The assignment of the 17 samples as reactive was a remote occurrence that was not reproducible and has not previously been observed.

Event Description

An incident occurred during the update of the run status from hold to valid.Seventeen samples from multiple pools were incorrectly assigned the conclusion of "reactive" after the procleix tigris instrument file was imported to procleix nat tracker software.

• Brand Name: PROCLEIX NAT TRACKER
• Type of Device: BLOOD ESTABLISHMENT COMPUTER SOFTWARE
• Manufacturer (Section D): GRIFOLS DIAGNOSTIC SOLUTIONS INC.; 4560 horton street; emeryville CA 94608
• Manufacturer (Section G): GRIFOLS DIAGNOSTIC SOLUTIONS INC.; 4560 horton street; emeryville CA 94608
• Manufacturer Contact: alisha mcreynolds ; 4560 horton street; emeryville, CA 94608 ; 5109235046
• MDR Report Key: 7307555
• MDR Text Key: 101693113
• Report Number: 1000124057-2018-00001
• Device Sequence Number: 1
• Product Code: MMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK110060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SOFTWARE V3.0
• Device Catalogue Number: 10009130
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2018
• Initial Date FDA Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1