MAUDE Adverse Event Report: WALLAC OY, SUBSIDIARY OF PERKINELMER SPECIMEN GATE LABORATORY SOFTWARE; DATA PROCESSING SOFTWARE

Model Number VERSION 1.8

Device Problems False Negative Result (1225); Incorrect Or Inadequate Test Results (2456); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2016

Event Type  malfunction  

Manufacturer Narrative

Correction of the cut-off values is managed through a controlled change process.The change process was initiated and the correction will be implemented according to the customer's schedule.

Event Description

The (b)(6) uses specimen gate laboratory (sgl) software during the analysis of newborn screening specimens.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.In 2012 the customer requested changes to the leucine analyte and leucine/phenylalanine ratio (leu/phe) reference range and cut-off values.The leucine/phenylalanine ratio is applied as three cut-off values based on age of newborn at time of collection.The specimen gate laboratory changes were prepared in the software by perkinelmer and implemented for the customer on 3/20/2013.In the changes implemented, two mathematical symbols for the leu/phe ratio were incorrectly programmed.Instead of the mathematical symbol for 'equal to or greater than' being used, only the 'greater than' symbol was used.On (b)(6) 2016 the customer reported to perkinelmer that a sample had not flagged properly.The level of leucine and the ratio of amino acids leucine and phenylalanine present in dried blood spot specimens are used as markers to aid in screening newborns for maple syrup urine disease.An elevated leu/phe ratio is one indicating factor of the disease.The ratio is only applied when the leucine level is elevated.In this incident, the result analysis when compared to the reference range was flawed for the ratio.The cut-off value for the leu/phe ratio was programmed as >5.0 umol/dl instead of the intended 'equal to or greater than' 5.0umol/dl.Samples with results at exactly 5.0 umol/dl would not be flagged as elevated.The phe/leu ratio from the repeat analysis of sample (b)(6) was 5.0umol/dl, not elevated according to the incorrect cut-off value.The (b)(6) laboratory contacted perkinelmer on (b)(6) 2016 inquiring about the failed flag.Investigations revealed that the 'equal to or greater than' mathematical symbol in the cut-off value was incorrect.The lab personnel reviewed the data and chose not to report the amino acid disorder and msud analyte markers as abnormal.Sample (b)(6) was reported as normal for the amino acid disorders on (b)(6) 2016.Regardless of the normal amino acid result reporting, the case was referred for follow-up assessment due to the abnormal result reporting for other disorders that the specimen was tested.The patient was referred for metabolic consultation.The laboratory has confirmed that allo-isoleucine second tier analysis was performed on the newborn, and that the result was normal.No other patients were affected by the incorrect cut-off value.

• Brand Name: SPECIMEN GATE LABORATORY SOFTWARE
• Type of Device: DATA PROCESSING SOFTWARE
• Manufacturer (Section D): WALLAC OY, SUBSIDIARY OF PERKINELMER; mustionkatu 6; turku, FI 20 750; FI FI 20750
• Manufacturer (Section G): WALLAC OY, SUBSIDIARY OF PERKINELMER; mustionkatu 6; turku, FI 20 750; FI FI 20750
• Manufacturer Contact: ann-christine fagerstrom ; mustionkatu 6; turku, FI 20-750 ; FI FI 20750 ; 3582 2678
• MDR Report Key: 6253052
• MDR Text Key: 64926447
• Report Number: 8043909-2017-00001
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/15/2017

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: No Information
• Device Model Number: VERSION 1.8
• Device Catalogue Number: 5002-0180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/14/2016
• Initial Date FDA Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 7 DA