MAUDE Adverse Event Report: WALLAC OY_PERKIN ELMER 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 perkinelmer.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 perkinelmer 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 reported on (b)(6) 2015 as normal for citrulline analysis although the tested value for the analyte was above the established reference range cut-off.Due to the elevated citrulline measurement, the sample should have been retested prior to reporting; however, 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.The sample was retested on (b)(6) 2015 after discovery of the error.The repeat citrulline results were well below the corrected cut-off.No update to the previously released report was necessary.There was no impact to patient welfare and no effective delay in reporting.

• Brand Name: SPECIMIN GATE LABORATORY
• Type of Device: DATA PROCESSING SOFTWARE
• Manufacturer (Section D): WALLAC OY_PERKIN ELMER; 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: 5308017
• MDR Text Key: 33835155
• Report Number: 8043909-2015-00028
• 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: 16 DA
• Patient Weight: 4