MAUDE Adverse Event Report: WALLAC OY_PERKINELMER SPECIMEN GATE LABORATORY; DATA PROCESSING SOFTWARE

Device Problems Computer Software Problem (1112); Incorrect, Inadequate or Imprecise Result or Readings (1535); Visual Prompts will not Clear (2281); Problem with Software Installation (3013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2017

Event Type  malfunction  

Manufacturer Narrative

See 806 report number 8043909-03/04/2017-002-c related to recall r2017003, res 76648.The malfunction has not lead to any serious injury or death events, thus the reason there is no information specified in section a.This report is being filed based on the potential for harm to occur if the issue were to recur in certain situations.The reason for the issues is a potential additional recalculation of the assay(s) without being prompted by the user.The recalculation is caused by an error in the configuration of the result calculation.This configuration does not clear the software memory and the manual calculations remain active events until the result viewer is closed.When the user initiates a manual calculation for subsequent assay(s), the software incorrectly performs all un-cleared and active calculation events.As a result, already accepted assays may be recalculated.The issue occurs only if the customer specific result calculation configurations are different for the assays concerned and there are multiple assays manually calculated within the same result viewer session.There is potential for calculated results to change if: demographics information is changed between the initial, manual calculation and the unintended recalculation when the changed demographic information is utilized in result calculation logic.There are manual changes to data, results, result codes, flags, etc.Prior to the unintended recalculation and within the same result viewer session.The issue causes an error during the manual calculation of a subsequent assay.If there were no changes to data, demographics, results, result codes, flags, etc.Prior to the unintended recalculation, the data and results will not be affected by the recalculation.The memory is cleared when specimen gate result viewer is closed.Therefore, issues are limited to those assays which are manually calculated and then followed by subsequent calculations of other assays without closing the result viewer between.

Event Description

Several laboratories that conduct testing for newborn screening use 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.Sgl is a class i medical device intended to store, retrieve, and process the data.The specimen gate laboratory product consists of several modules and components.The result viewer is one component with a user interface.The result viewer allows the user to view and effectively manage the results measured from different assays.The result viewer also allows the user to browse assay runs and assay history as well as other related data in various ways.For a particular assay run, the user can view the individual patient results as well as information about the assay calibration and the quality control data.We have become aware that if manual result calculations are performed for two or more different assays without closing the specimen gate laboratory result viewer between the manual calculations, an issue may occur.The issue may cause the data associated with the manually calculated assays to be unintentionally changed without notification to the user and may affect already accepted assays.The changes may include e.G.Discarding previous manual changes made to results, result codes, other editable information, or flags that have been added for a specimen, plate or the assay in question.It has also been identified that the issue may cause procedural anomalies such as the creation of extra answer records (test orders), in the specimen handling workflow.Recall consideration process was initiated due to the issue and a health hazard evaluation and recall determination was performed.Based on these, decision on reporting a near incident (this report) was made.No reports have been received that death or serious injury has occurred.However, it was assessed that the issue could lead to death or serious injury if reoccurring due to possibility of a false negative screening result for a true positive specimen in the worst case.A recall r2017003 has also been initiated and reported to fda (res 76648, 806 report number 8043909-03/04/2017-002-c).There have been several complaints identified as relating to the issue described above, but no adverse events have been reported.Complaint notifications 200270484, 200224703, 200187676, 200208211, 200210234, 200243223, and 200305950 are the result of this issue.

• Brand Name: SPECIMEN GATE LABORATORY
• Type of Device: DATA PROCESSING SOFTWARE
• Manufacturer (Section D): WALLAC OY_PERKINELMER; mustionkatu 6; finland, FI-20 750; FI FI-20750
• Manufacturer Contact: ann-christine fagerstrom ; mustionkatu 6; turku 20750 ; 0013582267
• MDR Report Key: 6407793
• MDR Text Key: 70110159
• Report Number: 8043909-2017-00048
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/15/2017

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/17/2017
• Initial Date FDA Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Removal/Correction Number: R2017003
• Patient Sequence Number: 1