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

Model Number	54794
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the device is not available for return.An investigation based on the information provided and a device history record (dhr) review has been requested.A supplemental report will be submitted upon completion.
Event or Problem Description
The customer reported that there was a barcode misread on a statstrip wireless meter (1.86) s/n: (b)(4).The user facility reported that the meter scanned patient barcode # (b)(6) as (b)(6).The facility is continuing to utilize the meter, therefore; no sample will be returned for evaluation.There was no reported patient harm or intervention required.
Additional Manufacturer Narrative
Additional and corrected information: b4,g7, h2, h6, h10 udi - (b)(4).The customer reported that there was a barcode misread on a statstrip wireless meter.The facility reported that the meter scanned patient barcode # (b)(6) as # (b)(6).The facility is continuing to utilize the meter, therefore; no sample was returned to nova for evaluation.There was no reported patient harm or intervention.Previously opened and investigated incidents from the customer facility determined that the root cause for the patient misreads is attributed to the user facility using poor quality 1d barcodes that were printed using code -39 symbology.Code-39 is no longer industry standard, and has a higher substitution failure rate than code-128 and much higher than the standard 2d barcodes available.This failure mode does not represent a systemic issue or a failure of the meter to perform as intended.The failure mode is directly related to the quality of the barcode being generated by the customer.Based on the poor grading of the barcode, root cause of misreads is most likely due to poor barcode quality.Based on the investigation, nova suggested to prevent barcode mis-reads in the future, that the customer should change from a 1d to a 2d barcode, which would greatly reduce the chances of a barcode misread.Trending will be monitored for this and or similar complaints.
Additional Manufacturer Narrative
Additional information: h4, h10.Corrected information: d5, g4, g7, h1, h2.The device history record (dhr) review included an assessment of the production, testing and release of the meter.No abnormalities or concerns were observed; the dhr indicated that the release product met all specifications.There is currently a pending investigation and further details will be provided in an additional supplemental report.

• Brand Name: STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect street; waltham,
• MDR Report Key: 10001691
• Report Number: 1219029-2020-00033
• Device Sequence Number: 16667368
• Product Code: PZI
• UDI-Device Identifier: 00385480547901
• UDI-Public: 00385480547901
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K181043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/14/2020

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
• Operator of Device: Health Professional
• Device Model Number: 54794
• Device Catalogue Number: 54790
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2020
• Supplement Date Received by Manufacturer: 04/28/2020; 04/28/2020
• Initial Report FDA Received Date: 04/27/2020
• Supplement Report FDA Received Date: 05/22/2020; 06/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1