MAUDE Adverse Event Report: WALLAC OY, PERKINELMER SUBSIDIARY 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 09/18/2014

Event Type  malfunction  

Event Description

The (b)(6) state public health newborn screening laboratory uses the perkinelmer 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 georgia the result code "tbc" means "to be confirmed".The software will apply this result code to an analytical 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 specimen gate laboratory module and into sgsc by the laboratory, samples punched from the dried blood spots and testing begun for the georgia defined disorder panel.One of the in vitro diagnostic kits run by the laboratory is multiplexed and generates results for 43 analytes.The software is designed to create a record for the patient for 1 of the 43 analytes as a placeholder in the database.Normally once the testing on the instrument for the 43 analytes is completed, the results are imported from the instrument to specimen gate laboratory module; and all 43 results become records in the database.However, the laboratory technician noticed an analytical value for the patient sample outside the reference range for 1 of the 43 analytes when viewing the test results on the instrument before the results were imported into sgsc.The technician decided to "custom" punch new dried blood spots samples to repeat the testing.This action by the technician is not part of the routine procedural workflow for the laboratory.When the 43 initial results were imported into specimen gate laboratory module, the software recognized the analytical value outside the reference range and tagged the sample with the tbc result code.At this stage a technician reviews the initial test results, after import, and accepts them.This action creates a request in the software to repeat the testing on the sample.The record associated with the automated repeat request has a higher priority than that associated with the initial test result records.The higher priority signals to the software to use those repeat results with the higher priority as the final reportable result when imported.At this point, the "premature" repeat testing results from the technician's "custom" punching were imported from the instrument into sgsc.Because these "custom" punch repeat testing results were a procedural deviation, the results were assigned a lower priority than the initial test results in sgsc.The laboratory then deleted the automated repeat request generated by sgsc, because the testing was already completed through the customer punch sequence and authorized the results to progress for reporting.At this point the initial results with the result code tbc had the highest priority and were advanced for reporting.In the reporting phase, sgsc evaluates any result codes associated with the analytical result against a library of defined result codes which directs the software which analytical result determination to print in the report.In the routine procedure workflow of the laboratory, the tbc result code should not reach the reporting phase and therefore is not defined in the result code library.When sgsc evaluated the tbc result code, the code was not found in the defined result code library.In this situation sgsc is configured to use a default determination which is "normal".The (b)(6) laboratory configuration at installation is programmed to release in the report only the determination (not the actual analytical result) when the analytical results are within normal limits.When an analytical result is not within normal limits the report contains the marker (analytes) name, the analytical results and the determination.The patient report released on sep 18, 2014 by the laboratory displayed the incorrect result determination of "normal".(b)(6) has a relationship with the (b)(6) laboratory where it receives the newborn screening data and periodically reviews the data as part of a cooperative arrangement between the two entities.(b)(6) identified the discrepant analytical result value and reported determination for the newborn and notified the (b)(6) laboratory on nov 21, 2014.The (b)(6) laboratory issued a corrected patient report on nov 24, 2014.Diagnostic testing was requested on nov 25, 2014 and the laboratory obtained feedback that the newborn was doing well.The diagnostic test result was received on dec 16, 2014 confirming the newborn did not have medium-chain acyl-coa dehydrogenase (mcad) deficiency.

• Brand Name: SPECIMEN GATE - SCREENING CENTER
• Type of Device: DATA PROCESSING SOFTWARE
• Manufacturer (Section D): WALLAC OY, PERKINELMER SUBSIDIARY; 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: 5048037
• MDR Text Key: 26651519
• Report Number: 8043909-2015-00001
• 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
• Report Date: 08/18/2015

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 1.6
• 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: Not provided
• Initial Date FDA Received: 09/01/2015
• 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: R2015006
• Patient Sequence Number: 1
• Patient Age: 7 DA
• Patient Weight: 3