STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
Received Apr 27, 2020 · Event occurred Apr 15, 2020
Report 1219029-2020-00033 · MDR key 10001691
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
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.
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
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.
Description of Event or Problem
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.