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

Model Number VERSION 1.6

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 07/20/2016

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2015, (b)(6) initiated recall z-0166-2016 for specimen gate screening center.(b)(6) was issued the recall letter on (b)(6) and the signed response form was received the same day.(b)(6)has been working with the (b)(6) newborn screening lab to identify the result code classifications impacted by the software anomaly.Since the recall issuance(b)(6) newborn screening lab have held routine meetings to identify and resolve the result code classifications.Implementation of the final corrective action is targeted to be complete by (b)(6) 2016.

Event Description

The (b)(6) public health newborn screening laboratory uses the (b)(6) specimen gate screening center (sgsc) software (a class i medical device) to store, retrieve, and process the data associated with specimen testing including but not limited to patient demographics, tests ordered, test results, test result determination (interpretation), quality control results, and result codes (flags) that may be associated with the specimen from its entry into the laboratory workflow until patient report is generated and released.When sgsc software is installed, 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.This laboratory specific logic automates the flow of the specimen through the laboratory.The customer defines the nomenclature used for their result codes (flags), and when the software encounters the predefined result code the software processes the specimen according to the logic associated with the result code.For instance in (b)(6) the result code "tbc" means "to be confirmed".The software will apply this result code to an initial analytical result that is outside of the reference range.The software then based on the tbc result code flags the specimen as one which requires repeat testing to be performed.To perform the repeat testing, new punches of the dried blood spot specimen are required; the software identifies this to the customer.The software is configured during installation based on the procedural workflow of the laboratory.When a laboratory technician deviates from their routine procedural workflow the software may not be able to recognize the deviation and account/correct for the event if the specific procedural deviation wasn't defined in the software during installation.In this specific scenario a newborn sample was entered into sgsc by the laboratory, samples were punched from the dried blood spots and testing was completed for the (b)(6) defined disorder panel.One of the tests run by the laboratory, referenced as apga, generates results for both the galt and biotinidase markers.When the apga galt marker result is abnormal, a tgal screen is then ordered.The tgal test profile defined by (b)(6) includes running tests for tgal and galt markers.When the apga biotinidase result is abnormal, the apga assay is identified for repeat testing which would include repeat testing of the btd and galt markers.In this specific scenario both galt and biotinidase results were abnormal in the original apga assay and the laboratory repeated the btd marker, and within the tgal profile ran both tgal and galt.Upon apga repeat, the biotinidase was normal, but galt remained abnormal.Upon tgal testing the tgal was normal, but galt remained abnormal.The report should have resulted in an "abnormal" determination (galt repeat abnormal, tgal repeat normal), however, on (b)(6) 2016 the reported result determination was "normal" for both galt and tgal.The correct disorder comment was included on the report by the laboratory: "test for galt enzyme defect is positive, which indicates possible galactosemia.If not previously contacted by the emory newborn screening follow-up program, please contact them at (b)(6)." a corrected report was released two days later on (b)(6) 2016.Due to the abnormal screen report, a repeat specimen was received for testing and was tested on (b)(6).The repeat specimen tested normal for galt.In the reporting phase, sgsc evaluates result codes associated with the analytical result against a library of defined result codes which directs the software on which analytical result determination to print in the report.During sample punching an issue occurred which led to one of the confirmation apga assay to be identified as initial, producing tbc result codes.In the routine procedure workflow of the laboratory, the tbc result code (indicating initial test phase) should not reach the reporting phase and therefore is not defined in the result code library for reporting.In this situation, encountering an undefined result code in the reporting phase, sgsc is configured to use a default determination which is "normal".In the event there is more than one assay for a single marker, such as in this case for galt, the order in which the confirmation samples for the tests are punched dictates which result is printed in the report.The last assay run is reported by sgsc.In this case, it was the apga galt result reported on the original report.The laboratory chose to report the galt result from the tgal assay instead of the apga assay when the corrected report was created.Both test results were abnormal for galt.

• Brand Name: SPECIMEN GATE SCREENING CENTER
• 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: 5886886
• MDR Text Key: 52737433
• Report Number: 8043909-2016-00001
• 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: 08/18/2016

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 1.6
• Device Catalogue Number: 5002-0500
• Device Lot Number: NONE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/22/2016
• Initial Date FDA Received: 08/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0166-2016
• Patient Sequence Number: 1
• Patient Age: 49 HR
• Patient Weight: 1