STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
Received Aug 27, 2019 · Event occurred Jul 25, 2019
Report 1219029-2019-00041 · MDR key 8935507
Device
Generic name
Glucose Test System
Manufacturer
Nova Biomedical Corp.Model number
54794Catalog number
54790
Product problems
- Patient Data Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional 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.
Description of Event or Problem
NOVA STATSTRIP HOSPITAL METER MIS-SCANNED PATIENT BARCODE AND REPORTED TEST RESULT UNDER A DIFFERENT PATIENT ID.