MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. STATSTRIP GLUCOSE HOSPITAL METER SYSTEM; GLUCOSE TEST SYSTEM

Model Number 54794

Device Problem Patient Data Problem (3197)

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

Event Date 07/25/2019

Event Type  malfunction  

Manufacturer Narrative

No patient impact or adverse event reported.Investigation is on-going, patient barcode samples and statstrip meter returned to nova for evaluation.Customer stated that, "i spoke to the nurse who wasn't able to offer much insight.She sometimes scans the chart, sometimes the armband, and sometimes types the number in the meter.She doesn't remember what she did for this one on (b)(6).It is possible she scanned something completely different than a patient barcode.The meter is programmed to only accept a 7 digit number for the patient number so whatever she scanned must have been 7 digits which makes me think it wasn't a random barcode.I think the meter read the patient barcode incorrectly." exact patient barcode was not able to be identified but customer returned samples printed from each unit they use to produce patient barcodes.Supplemental report will contain details of nova's investigation once complete.

Event Description

Nova statstrip hospital meter mis-scanned patient barcode and reported test result under a different patient id.

• Brand Name: STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
• Type of Device: GLUCOSE TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454 3465
• Manufacturer (Section G): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454 3465
• Manufacturer Contact: taylor ward ; 200 prospect st; waltham, MA 02454-3465 ; 7816473700
• MDR Report Key: 8935507
• MDR Text Key: 168205583
• Report Number: 1219029-2019-00041
• Device Sequence Number: 1
• Product Code: PZI
• UDI-Device Identifier: 00385480547901
• UDI-Public: 00385480547901
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K181043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 54794
• Device Catalogue Number: 54790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Date Manufacturer Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1