MAUDE Adverse Event Report: WALLAC OY_A SUBSIDIARY OF PERKINELMER SPECIMIN GATE LABORATORY; DATA PROCESSING SOFTWARE

Model Number VERSION 1.9

Device Problems False Negative Result (1225); Device Operational Issue (2914); Output Problem (3005); Problem with Software Installation (3013)

Patient Problems Misdiagnosis (2159); No Consequences Or Impact To Patient (2199)

Event Date 06/25/2015

Event Type  malfunction  

Event Description

The (b)(6) health services uses specimen gate® laboratory (sgl), a software product provided by (b)(4).Sgl contains a database and possesses functionality which enables laboratories to track specimens as they navigate through the laboratory with audit trails, security, and handling logic based on customer rules for qc, result-to-reference range analysis, result flagging, etc.Sgl is a class i medical device intended to store, retrieve, and process the data.The (b)(6) health services newborn screening laboratory uses the (b)(4) specimen gate® laboratory (sgl), version 2015.When the software is deployed, configurable settings are programmed based on the customer preferences.For instance, each laboratory enters their specific population based reference ranges that are used to evaluate if a patient's test results are normal, below or above the reference range and require further action such as repeat testing.In this incident, the results of a newborn dried blood spot sample tested on (b)(6) 2015 were determined as normal for citrulline analysis although the tested value for the analyte was above the established reference range cut-off.The cut-off was incorrect within the software due to a transposition of numbers upon entry.The cut-off was entered as 150 instead of the intended 105.This error was discovered before the patient results were reported.Due to the elevated citrulline measurement and per routine protocol, the sample was retested on (b)(6) 2015 and an accurate report was released on (b)(6) 2015.There was no impact to patient welfare and no delay in reporting.

• Brand Name: SPECIMIN GATE LABORATORY
• Type of Device: DATA PROCESSING SOFTWARE
• Manufacturer (Section D): WALLAC OY_A SUBSIDIARY OF PERKINELMER; mustionkatu 6; finland, turku FI-20 750; FI FI-20750
• Manufacturer (Section G): WALLAC OY_A SUBSIDIARY OF PERKINELMER; mustionkatu 6; finland, turku FI-20 750; FI FI-20750
• Manufacturer Contact: ann-christine fagerstrom ; mustionkatu 6; turku, 20750 ; FI 20750 ; 3582267812
• MDR Report Key: 5308039
• MDR Text Key: 33835172
• Report Number: 8043909-2015-00030
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2015

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: Other
• Device Model Number: VERSION 1.9
• Device Catalogue Number: 5002-0180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/25/2015
• Initial Date FDA Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 1 MO