JAUNDICE JM105

Description of Event or Problem

THE CUSTOMER REPORTED LOW READING TCB APPROX 80UMOL/L AGAINST SBR:TCB 173 VS SBR 250 UMOL/L, TCB 292 VS SBR 378 UMOL/L. NO DATE OR EVENT OR OTHER INFORMATION WAS PROVIDED. NO ADVERSE PATIENT IMPACT OR DEATH REPORTED.

Description of Event or Problem

THE CUSTOMER REPORTED LOW READING TCB APPROX 80UMOL/L AGAINST SBR:TCB 173 VS SBR 250 UMOL/L, TCB 292 VS SBR 378 UMOL/L. NO DATE OR EVENT OR OTHER INFORMATION WAS PROVIDED. NO ADVERSE PATIENT IMPACT OR DEATH REPORTED.

Additional Manufacturer Narrative

IT WAS REPORTED TO DRAEGER THAT THE JM105 HAD LOWER READINGS THAN THE TOTAL SERUM BILIRUBIN (TSB). NO ADVERSE PATIENT IMPACT WAS REPORTED. THE CUSTOMER RESPONDED BY ANSWERING SOME OF THE CLINICAL QUESTIONS HOWEVER, THE CUSTOMER SUPPLIED ONLY 2 JM105 VALUES. DESPITE MANY ATTEMPTS ASKING FOR THE CUSTOMER TO PROVIDE A DATA SHEET, WHICH INCLUDES CRUCIAL INFORMATION TO DETERMINING CLINICAL USE AND VALUES BEING RECEIVED, THIS INFORMATION WAS NOT MADE AVAILABLE. ONE OF THE TSB READINGS PROVIDED (21.9) IS BEYOND THE SCOPE OF THE JM105. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) THE MEASUREMENT RANGE FOR THE JM105 IS 0.0 MG/DL TO 20.0 MG/DL. THE CUSTOMER PROVIDED THE TCB READING IN THIS CASE TO BE 16.9 WHICH WOULD LIKELY PROMPT CLINICIANS TO PROVIDE FURTHER CARE HOWEVER, WITHOUT THE ADDITIONAL CLINICAL DATA (HOURS LIFE OF THE PATIENT, SKIN TYPE, BLOOD PROCESSING TIME) A DEFINITIVE DETERMINATION CANNOT BE MADE. IN ADDITION, THE IFU STATES THAT THE JM105, "IS NOT INTENDED AS A STAND-ALONE SCREENING DEVICE FOR DIAGNOSIS OF HYPERBILIRUBINEMIA. IT IS USED AS A SCREENING DEVICE WITH OTHER CLINICAL SIGNS AND LABORATORY MEASUREMENTS." THE METER WAS RETURNED TO DRAGER FOR ANALYSIS AND THE DRAEGER FIELD SERVICE ENGINEER (FSE) FOUND THE PRE-CALIBRATION VALUES OF THE METER TO BE WITHIN RANGE OF THE TOLERANCES GIVEN ON THE BASE. THE DRAEGER FSE RECALIBRATED THE DEVICE UNDER WARRANTY FOR CUSTOMER SATISFACTION, PRODUCED A CALIBRATION CERTIFICATE CERTIFYING THE DEVICE WAS WITHIN THE TARGET RANGE AND READY FOR CLINICAL USE. DUE TO THE LACK OF TCB AND TSB DATA AND OTHER INFORMATION INDICATING HOW THE USER WAS TAKING READINGS, THE SKIN TYPE AND HOURS OF LIFE OF THE PATIENTS THAT CAN AFFECT VALUES, OR THE NOMOGRAM USED BY THE CUSTOMER TO PROMPT FURTHER CARE, A ROOT CAUSE CANNOT BE DETERMINED. THE DEVICE WAS RETURNED TO THE CUSTOMER AND THE CUSTOMER WAS RETRAINED ON HOW TO USE THE DEVICE. NO FURTHER ISSUES HAVE BEEN REPORTED.