MAUDE Adverse Event Report: WALLAC OY, SUBSIDIARY OF PERKINELMER SPECIMEN GATE LABORATORY; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Model Number 5002-0180

Device Problems Computer Software Problem (1112); False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Neonatal Deformities (1974); No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 09/22/2019

Event Type  malfunction  

Manufacturer Narrative

Correction of the configurable settings related to lsd assay result calculation was implemented on (b)(6) 2020.

Event Description

The (b)(6) department of health newborn screening (nbs) laboratory uses specimen gate laboratory (sgl) software during the analysis of 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.When sgl software is installed, configurable settings are programmed based on the procedural workflow of the laboratory and the customer preferences.One of the assays that is run by the laboratory as part of the (b)(6) defined disorder panel is lysosomal storage disorders (lsd).The activity levels of gaa; galc; and idua present in dried blood spot specimens are used as markers to aid in screening newborns for the lysosomal storage disorders pompe, krabbe, and mps-1, respectively.A decreased activity is indicative of the disorder.On (b)(6) 2020 the customer reported to perkinelmer that the quality control flagging and result calculation was not working as expected concerning the lsd assay.Investigations revealed an error in the configurable settings of the lsd assay.Due to this error result blank subtraction was not done as part of result calculation by the sgl as intended.The calculated results were incorrectly high as the average of blanks on each plate was not subtracted from control and sample activities to get the final reportable results for gaa, galc, and idua.An agreed change had been implemented to the configurable settings for lsd assay on (b)(6) 2019 and the calculation error was unintentionally introduced to the settings during the implementation of the change.The settings were corrected to perform blank subtraction as part of the result calculation on (b)(6) 2020.The reported lsd results between (b)(6) 2019 and (b)(6) 2020, were reviewed to identify all specimens that were incorrectly reported as normal instead of with elevated risk.Specimens with elevated risk for any of the lysosomal storage disorders should have either undergone repeat testing (confirmation) per (b)(6) testing algorithm (for positive initial test) or undergone follow-up consisting of genetic consultation and diagnostic testing (for positive confirmation test).Altogether 14 affected specimens were found in the review, 11 specimens had incorrect results in initial test and 3 specimens had incorrect result in confirmation test.Repeat testing (confirmation) was performed for affected 11 specimens that should have been positive in initial test.Confirmation test results were within normal limits for all 11 specimens.

• Brand Name: SPECIMEN GATE LABORATORY
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): WALLAC OY, SUBSIDIARY OF PERKINELMER; mustionkatu 6; turku, 20750 ; FI 20750
• Manufacturer (Section G): WALLAC OY, SUBSIDIARY OF PERKINELMER; mustionkatu 6; turku, 20750 ; FI 20750
• Manufacturer Contact: rina wahlroos ; mustionkatu 6; turku, FI-20-750 ; FI FI-20750
• MDR Report Key: 9673899
• MDR Text Key: 221573151
• Report Number: 8043909-2020-00001
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5002-0180
• Device Catalogue Number: 5002-0180
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2018
• 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 Outcome(s): Other