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

Model Number VERSION 1.6

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Operational Issue (2914); Output Problem (3005); Problem with Software Installation (3013)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/08/2015

Event Type  malfunction  

Event Description

The (b)(6) state public health newborn screening laboratory uses the perkinelmer screening center module of specimen gate (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 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.The newborn screening laboratory received 2 specimens for the patient.By protocol, two specimens should be sent for all babies born in (b)(6).The first specimen was received on (b)(6) 2015.The initial c0 was low, triggering a confirmation request.The confirmation was not tested by the laboratory, but the confirmation record was attached to a separate assay that the specimen was not punched to, causing incomplete results for the confirmation cud (carnitine uptake defect) so the laboratory was unable to print the report and contacted perkinelmer for assistance.Perkinelmer cancelled and unattached the records that were incorrectly associated with the separate assay.A review item was created for this specimen on (b)(6) 2015 at 10:45 am preventing the report from being printed.The laboratory closed the review item on (b)(6) 2015 at 11:36 am allowing the report to be printed, displaying normal for the cud disorder even though testing needed to be confirmed.The second specimen was received on (b)(6) 2015, analyzed and reported as normal for cud disorder on (b)(6) 2015.The patient report released did not contain any erroneous content.(b)(4).

• 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: 5059461
• MDR Text Key: 27533805
• Report Number: 8043909-2015-00015
• 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: company representative
• Reporter Occupation: Other
• Remedial Action: Other
• Report Date: 08/20/2015

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: No Information
• Device Model Number: VERSION 1.6
• Device Catalogue Number: 5002-0050
• 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: 09/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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: 10 DA
• Patient Weight: 3