JAUNDICE - JM103/105

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER THAT THE JM105 READING WAS MISINTERPRETED BY THE MIDWIFE WHO SENT A REPORT TO THE FRENCH COMPETENT AUTHORITY. THE DEPARTMENT'S PEDIATRICIAN CONFIRMED THERE NO DEVICE ERROR AND THERE WAS NO REASON FOR A REPORT TO HAVE BEEN SENT. THE PATIENT RECEIVED APPROPRIATE TREATMENT. ON (B)(6) 2024 DRAEGER MET WITH THE CUSTOMER AND WENT OVER THE CORRECT PROTOCOL FOR USING THE JM105 FOR DATA COLLECTION. THE CUSTOMER WAS ADVISED TO MEASURE THE TRANSCUTANEOUS BILIRUBIN LEVELS ON BABIES FOR WHOM A BLOOD BILIRUBIN ANALYSIS WAS PLANNED, AND THEY WERE TOLD TO PLOT BOTH VALUES IN THE PROVIDED DATA SHEET. THEY WERE REMINDED THAT THE TIME BETWEEN SAMPLING AND MEASUREMENT OF TRANSCUTANEOUS BILIRUBIN SHOULD NOT EXCEED ONE HOUR AND A SERIES OF TEN MEASUREMENTS IS SUFFICIENT FOR SEEING A CORRELATION BETWEEN TRANSCUTANEOUS AND BLOOD VALUES. IN CONCLUSION, THIS COMPLAINT WAS OPENED DUE TO THE CUSTOMER'S MISINTERPRETATION OF THE DEVICE READING.

Description of Event or Problem

IT WAS REPORTED A BLOOD SAMPLE WAS TAKEN FROM A BABY AT 8 DAYS OF AGE, FOR NON-WEIGHT GAIN; THE BABY WAS POTENTIALLY OUTGOING. HIS TRANSCUTANEOUS BILIRUBIN WAS MEASURED AT 252 MICROMOI/L (OUTSIDE THE PHOTOTHERAPY CURVE). AT THE TIME OF THE CHECK-UP, HIS PLASMA BILIRUBIN MEASUREMENT = 352 MICROMOI/L, WHICH EQUALS INDICATION FOR PHOTOTHERAPY TREATMENT. THE BABY RECEIVED 3 SESSIONS OF 3H00 OF PHOTOTHERAPY. READINGS OF THE JAUNDICE METER THAT ARE OUTSIDE SPECIFICATION IN THE LOWER DIRECTION MAY NOT BE OBVIOUS TO THE USER AND MAY NOT PROMPT A BLOOD TEST FOR VERIFICATION WHICH COULD LEAD TO A DELAY IN REQUIRED TREATMENT. IN THIS CASE THERE WAS NO ADVERSE PATIENT IMPACT.

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED A BLOOD SAMPLE WAS TAKEN FROM A BABY AT 8 DAYS OF AGE, FOR NON-WEIGHT GAIN; THE BABY WAS POTENTIALLY OUTGOING. HIS TRANSCUTANEOUS BILIRUBIN WAS MEASURED AT 252 MICROMOI/L (OUTSIDE THE PHOTOTHERAPY CURVE). AT THE TIME OF THE CHECK-UP, HIS PLASMA BILIRUBIN MEASUREMENT = 352 MICROMOI/L, WHICH EQUALS INDICATION FOR PHOTOTHERAPY TREATMENT. THE BABY RECEIVED 3 SESSIONS OF 3H00 OF PHOTOTHERAPY. READINGS OF THE JAUNDICE METER THAT ARE OUTSIDE SPECIFICATION IN THE LOWER DIRECTION MAY NOT BE OBVIOUS TO THE USER AND MAY NOT PROMPT A BLOOD TEST FOR VERIFICATION WHICH COULD LEAD TO A DELAY IN REQUIRED TREATMENT. IN THIS CASE THERE WAS NO ADVERSE PATIENT IMPACT.