JAUNDICE - JM105

Additional Manufacturer Narrative

A COMPLAINT WAS RECEIVED REGARDING THE JM105 WHERE THE CUSTOMER REPORTED A DIFFERENCE IN THE TCB READINGS FROM THE METER WHEN COMPARED TO THE TOTAL SERUM BILIRUBIN (TSB). NO ADVERSE PATIENT IMPACT WAS REPORTED. THE CUSTOMER ONLY PROVIDED ONE READING (SBR IS 300 AND ON TCB MONITOR IT SHOWS 90) WHICH WHEN CONVERTED TO A TCB METER READING OF 5.22 MG/DL AND TSB/BLOOD READING OF 17.4 MG/DL, WOULD INDICATE A LOW READING OUTSIDE OF THE STANDARD 1.5 ACCEPTABLE DEVIATION DEFINED BY DRAGER. ADDITIONAL INFORMATION AND DATA WERE REQUESTED HOWEVER, ON (B)(6)2024 IT WAS CONFIRMED THAT THE CUSTOMER WAS NOT WILLING TO PROVIDE ANY FURTHER DATA. A DRAGER ENGINEER REPAIRED THE DEVICE AND ACCORDING TO SERVICE REPORT ORDER (B)(4), THE DEVICE WAS DISPLAYING THE "TIME FOR PERIODIC CALIB" MESSAGE AND IT WAS AGAIN STATED THAT THE CUSTOMER DECLINED TO ANSWER FOLLOW UP QUESTIONS. A NEW BATTERY WAS INSTALLED IN THE DEVICE BEFORE THE ENGINEER PERFORMED THE RECALIBRATION AND SENT THE UNIT BACK TO THE CUSTOMER. THE CALIBRATION CERTIFICATE LISTS THE DATE OF THE LAST CALIBRATION AS (B)(6)2023, WHICH WAS NEARLY 14 MONTHS PRIOR TO THE DATE OF EVENT LISTED IN THE COMPLAINT ((B)(6)2024). THE INSTRUCTIONS FOR USE CONFIRMS THAT WHEN THE DEVICE IS DUE FOR CALIBRATION, THE "TIME FOR PERIODIC CALIB" MESSAGE WILL APPEAR ON THE METER SCREEN EACH TIME IT IS TURNED ON. THE INSTRUCTIONS FOR USE ALSO INFORMS THE USER THAT INITIAL CALIBRATION FOR THE JM105 IS VALID FOR ONE YEAR, THAT RECALIBRATION IS RECOMMENDED EVERY 12 MONTHS AND THAT THE JM105 SHOULD BE PERIODICALLY COMPARED TO SERUM BILIRUBIN RESULTS FOR QUALITY CONTROL PURPOSES.

Description of Event or Problem

IT WAS REPORTED THAT THE JAUNDICE METER, JM105, WAS ONE MONTH OVERDUE FOR CALIBRATION. THE CUSTOMER NOTICED THAT THE METER WAS GIVING LOW READINGS. FOR EXAMPLE, WHEN THE PATIENT'S SERUM BILIRUBIN (SBR) WAS 300, THE METER WOULD GIVE A READING OF 90. THE LOW READINGS WERE FOUND AFTER IT WAS USED ON A FEW PATIENTS, AND IT WAS AT THAT POINT THAT THE CUSTOMER CHECKED THE METER AND REALIZED IT NEEDED CALIBRATION. THE DEVICE WAS TAKEN OUT OF CLINICAL USE AND SENT TO DRAEGER FOR CALIBRATION. IT WAS STATED THAT THE CUSTOMER ALWAYS KEPT THE METER ON THE DOCKING STATION AND THE NURSE CHECKED THE DEVICE'S CHARGE ONCE A DAY.

Additional Manufacturer Narrative

THE INVESTIGATION HAS STARTED. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION.

Description of Event or Problem

IT WAS REPORTED THAT THE JAUNDICE METER, JM105, WAS ONE MONTH OVERDUE FOR CALIBRATION. THE CUSTOMER NOTICED THAT THE METER WAS GIVING LOW READINGS. WHEN THE PATIENT'S SERUM BILIRUBIN (SBR) WAS 300, THE METER GAVE A READING OF 90. AFTER NOTICING THE METER GAVE MULTIPLE LOW READINGS, THE CUSTOMER CHECKED THE METER AND REALIZED IT NEEDED CALIBRATION. THE DEVICE WAS TAKEN OUT OF CLINICAL USE AND SENT TO DRAEGER FOR CALIBRATION. IT WAS STATED THAT THE CUSTOMER ALWAYS KEPT THE METER ON THE DOCKING STATION AND THE NURSE CHECKED THE DEVICE'S CHARGE ONCE A DAY.