JAUNDICE JM105

Description of Event or Problem

THE CUSTOMER REPORTED A JAUNDICE METER 105 THAT HAD A LOW READING WHEN COMPARED TO BLOOD BILIARY. THE JM105 READ 280 WHILE THE BLOOD BILIARY WAS AT 417. NO ADVERSE PATIENT IMPACT OR PATIENT DEATH WAS REPORTED.

Additional Manufacturer Narrative

A COMPLAINT WAS RECEIVED ON 04SEP2024 REGARDING A JAUNDICE METER, JM105 THAT HAD LOWER READINGS WHEN COMPARED TO THE TOTAL SERUM BILIRUBIN (TSB) VALUES. THE DEVICE WAS TAKEN OUT OF USE AND SENT IN FOR SERVICE. THERE WAS NO PATIENT INJURY REPORTED. AS REPORTED THE JM105 GAVE A READING OF 280 BUT THE PATIENT'S TSB TAKEN AT THAT TIME GAVE A RESULT OF 417. ADDITIONAL INFORMATION REGARDING THE SPECIFIC EVENT AND USE OF THE METER WAS REQUESTED FROM THE CUSTOMER, BUT THEY WERE NOT ABLE TO PROVIDE ANY OTHER DATA FROM THE METER. IT WAS NOTED THAT THE DISCREPANCY WAS FOUND ON A PATIENT WITH WHITE SKIN, AT AN AGE OF 108 HOURS, THE READING OF 280 HAD BEEN TAKEN AT THE STERNUM, AND AFTER RECEIVING THIS MEASUREMENT, THE PATIENT WAS RE-HOSPITALIZED FOR FURTHER EVALUATION. UP UNTIL THIS EVENT, THE DEVICE WAS USED DAILY, AND THE METER WAS LAST CALIBRATED IN APRIL 2024. THIS WAS THE FIRST INSTANCE THE DEVICE READINGS SHOWED A DISCREPANCY WHEN COMPARED TO TSB SINCE THE LAST CALIBRATION. IT WAS ALSO CONFIRMED THAT THE PROPER USE OF THE JM105 WAS MET. THE DEVICE WAS SERVICED BY A DRAEGER SERVICE ENGINEER ON 01OCT2024. THE DEVICE RETURNED WITH A CHARGING BASE AND ON VISUAL INSPECTION, NO DEVIATIONS OR PHYSICAL DAMAGE WAS OBSERVED. THE JM105 PASSED ALL TEST PROCEDURES AND WAS RE-CALIBRATED AT A DEFAULT GAIN USING THE MASTER CHECKER SET NO. 49. THE DEVICE WAS TESTED AGAINST THE INTEGRATED CHECKER OF THE CHARGING BASE AND WAS FOUND TO BE WITHIN TOLERANCE. HOWEVER, AFTER CALIBRATION, IT WAS NOTICED THAT THE DEVICE WOULD INTERMITTENTLY NOT TURN ON AND THE DOCKING STATION INTERMITTENTLY DID NOT CHARGE. DRAEGER SERVICE REQUESTED A REPAIR DISPATCH AFTER THIS FINDING. ON 18OCT2024 THE DEVICE UNDERWENT SERVICE AGAIN DUE TO THE INTERMITTENT POWER ISSUE. THE MAIN PCB AND DOCKING STATION WERE REPLACED. THE METER WAS THEN TESTED FOR CERTIFICATION AND FOUND SUCCESSFUL RESULTS ALL WITHIN THE TOLERANCE RANGE. THE DEVICE WAS ALSO TESTED AGAINST THE INTEGRATED CHECKER BASE AND WAS WITHIN TOLERANCE. THE DEVICE WAS THEN SENT BACK TO BE RETURNED TO THE CUSTOMER FOR CLINICAL USE WITH INSTRUCTIONS TO FULLY CHARGE THE INTERNAL BATTERY BEFORE USE. CALIBRATION AND REPLACEMENT OF THE MAIN PCB AND DOCKING STATION RESOLVED THE REPORTED ISSUE. A SPECIFIC ROOT CAUSE FOR THESE ISSUES WAS NOT IDENTIFIED. THE DEVICE WAS SENT BACK TO THE CUSTOMER FOR CLINICAL USE.

Description of Event or Problem

THE CUSTOMER REPORTED A JAUNDICE METER 105 THAT HAD A LOW READING WHEN COMPARED TO BLOOD BILIARY. THE JM105 READ 280 WHILE THE BLOOD BILIARY WAS AT 417. NO ADVERSE PATIENT IMPACT OR PATIENT DEATH WAS REPORTED.