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); Output Problem (3005)

Patient Problem Congenital Defect/Deformity (1782)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

The configuration was updated on (b)(6) 2019.Following the updates it has been shown that the error no longer occurs.

Event Description

On (b)(6) 2020 perkinelmer was notified of an issue with newborn screening results reporting.The customer reported that a (b)(6) was diagnosed with sickle cell disease, but at the time of newborn screening the patient's report reflected a normal result.Review of the child´s newborn screening records showed that the initial result was abnormal.The confirmatory test was also abnormal.After the confirmatory results were available, the user manually entered the abnormal result into specimen gate laboratory.An investigation revealed that the abnormal result provided by the user had not been recorded in all expected fields in specimen gate laboratory resulting in an incorrectly reported screening result.Sixteen specimens were affected by the error.Two specimens had normal results and were processed correctly.Fourteen specimens had abnormal results and were reported incorrectly as normal.The fourteen includes the specimen of the (b)(6) patient discussed above plus thirteen specimens.The abnormalities should have been reported with a recommendation to obtain diagnostic testing, and are recommended to have consultation and further clinical follow up.The reported hgb results, inclusive from the time the laboratory began hgb testing, were reviewed to identify all specimens that were incorrectly reported.Seven affected specimens were found in the review.Two were identified by the lab at the time of testing and the results were updated and reported correctly.The other 5 were incorrectly reported.

• 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: mikaela toivonen ; mustionkatu 6; turku, 20750 ; FI 20750
• MDR Report Key: 11302026
• MDR Text Key: 251692249
• Report Number: 8043909-2021-00001
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 06438147153312
• UDI-Public: (01)06438147153312(10)1.07.00
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 5002-0180
• Device Catalogue Number: 5002-0180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other