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

Model Number	54790
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion a supplemental report will be submitted.
Event or Problem Description
On (b)(6) 2020 a customer reported to nova biomedical that there was a barcode misread while scanning a 1d barcode with a statstrip wireless meter (1.86) s/n: (b)(4).Patient's barcode number is (b)(6) but it was scanned as (b)(6) by the meter.There was no patient harm or medical intervention reported.
Additional Manufacturer Narrative
Additional and corrected information: b1, b4, g3, g6, h2, h4, h6, h10.Udi (b)(4).The customer reported that there was a barcode misread on a statstrip glucose hospital meter.The facility reported that the meter scanned patient barcode (b)(6).No patient impact or adverse event was reported.Statstrip meter and the actual patient barcode were returned to nova for evaluation.A device history record (dhr) review for the statstrip glucose hospital meter, s/n (b)(6) was performed by the senior quality control engineer.The review included an assessment of the production, testing, and release of the meter.No abnormalities or concerns were observed; the dhrs indicated that the released product met all specifications.Upon arrival of the meter and barcode, an investigation to validate the complaint was performed.Preliminary scan testing did not reveal any data capture failures.100 scans were performed on the supplied problem bar code along with several other marginal and good bar codes from different strip vials and generated codes printed at nova.Scans were also initiated with the meter battery in full and low charge state over a period of a few days, no problems found.The scanner window, camera, and the scanner connections were then inspected for any issues.The only problem found was that the scanner window had a buildup of chemical residue and some sort of hardened debris stuck to it.These obstructions could have possibly interfered with the data capture.The hardened debris was difficult to remove without damaging the scanner window.A couple of hundred scans were performed before and after inspection and cleaning with no issues.A picture is attached showing the solidified debris remaining on the scanner window after initial cleaning and prior to more aggressive removal.The returned barcode was scanned and passed with a b using code128 on the omron micro scan system.Previously opened and investigated incidents from the customer facility determined that the most likely 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
The complaint sample for the meter s/n: (b)(6) was returned on august 3, 2020 for evaluation.The evaluation is currently underway and upon completion of this investigation a final report will be provided.

• Brand Name: STATSTRIP GLUCOSE HOSPITAL METER
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect street; waltham, ma
• MDR Report Key: 10321090
• Report Number: 1219029-2020-00041
• Device Sequence Number: 2841819
• Product Code: PZI
• UDI-Device Identifier: 00385480547901
• UDI-Public: 00385480547901
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K181043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2020

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: 54790
• Device Catalogue Number: 54790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 07/22/2020; 08/03/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 08/21/2020; 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1