STATSTRIP GLUCOSE HOSPITAL METER
Received Sep 28, 2021 · Event occurred Sep 15, 2021
Report 1219029-2021-00041 · MDR key 12542019
Device
Product problems
- Patient Data Problem
- Patient Data Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
UDI: (B)(4). THE CUSTOMER IS LOCATED IN CANADA WHERE THE METER PART NUMBER IS 54794. AS THE MANUFACTURER, A SIMILAR DEVICE PART NUMBER FOR THE US TO REPORT IS 54790. THEREFORE, THE REPORT IS BEING SUBMITTED TO THE FDA UNDER 54790 AND THE SUBSEQUENT REPORT TO HEALTH CANADA WILL REFLECT 54794. THE FACILITY REPORTED PATIENT BARCODE SCAN ERROR ON A PATIENT'S IDENTIFICATION NUMBER. THEY DID NOT REPORT ANY PATIENT HARM OR INTERVENTION. THE FACILITY IS CONTINUING TO UTILIZE THE METER, THEREFORE; NO SAMPLE WAS RETURNED TO NOVA FOR EVALUATION. A DEVICE HISTORY RECORD (DHR) REVIEW FOR THE METER WAS PERFORMED. THE REVIEW INCLUDED AN ASSESSMENT OF THE PRODUCTION, TESTING, AND RELEASE OF THE PRODUCTS. NO ABNORMALITIES OR CONCERNS WERE OBSERVED; THE DHR INDICATED THE RELEASED PRODUCT MET ALL SPECIFICATIONS. PREVIOUSLY OPENED AND INVESTIGATED INCIDENTS FROM THE CUSTOMER FACILITY DETERMINED THE ROOT CAUSE FOR THE PATIENT MISREADS IS ATTRIBUTED TO THE USER FACILITY USING POOR QUALITY 1D BARCODES THAT WERE PRINTED USING CODE: (B)(4) SYMBOLOGY. CODE: (B)(4) IS NO LONGER INDUSTRY STANDARD AND HAS A HIGHER SUBSTITUTION FAILURE RATE THAN CODE: (B)(4) 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. THE ROOT CAUSE OF THE MISREAD IS MOST LIKELY DUE TO POOR BARCODE QUALITY. BASED ON THE ORIGINAL INVESTIGATION, NOVA SUGGESTED TO PREVENT BARCODE MIS-READS IN THE FUTURE, THE CUSTOMER SHOULD CHANGE FROMA 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.
Description of Event or Problem
THE CUSTOMER REPORTED THERE WAS A BAR CODE SCANNING ERROR ON A PATIENT'S IDENTIFICATION NUMBER WHILE USING A STAT STRIP (1.86) METER. THE INCIDENT OCCURRED ON SEPTEMBER 15, 2021. THE CUSTOMER STATES THEY ARE UNAWARE OF ANY POTENTIAL PATIENT HARM FROM THE BARCODE MISREAD AND WILL NOT BE RETURNING THE METER AS IT IS CURRENTLY IN USE AT THE FACILITY.