MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION STAT PROFILE PRIME CCS ANALYZER WITH SCANNER 2

Model Number 53657

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/18/2017

Event Type  malfunction  

Manufacturer Narrative

A review of the customer complaint information confirmed that the patient was not mistreated due to the identified software issue.Nova has also confirmed that this is the first complaint that we have received due to this reported software issue.Decision to initiate a field correction to immediately correct the software issue associated with the use of stat profile prime auto-cartridge quality control (a-qc) materials.The investigation is currently in process.

Event Description

Prime analyzer s/n (b)(4) failing to flag a patient critical ph level.

• Brand Name: STAT PROFILE PRIME CCS ANALYZER WITH SCANNER 2
• Type of Device: ANALYZER
• Manufacturer (Section D): NOVA BIOMEDICAL CORPORATION; 200 prospect st; waltham MA 02454
• Manufacturer (Section G): NOVA BIOMEDICAL CORPORATION; 200 prospect st; waltham MA 02453 3465
• Manufacturer Contact: rachel kula ; 200 prospect street; waltham, MA 02453 ; 7816473700
• MDR Report Key: 6651879
• MDR Text Key: 78029773
• Report Number: 1219029-2017-00006
• Device Sequence Number: 1
• Product Code: GKF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 05/22/2017

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: Health Professional
• Device Model Number: 53657
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2017
• Initial Date FDA Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2015
• 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 Age: 54 YR