JAUNDICE JM105

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE JAUNDICE METER (JM) 105 GAVE "MOSTLY" LOW READINGS. NO ADVERSE PATIENT IMPACT OR PATIENT DEATH WAS REPORTED.

Additional Manufacturer Narrative

A COMPLAINT WAS RECEIVED REGARDING A JM105 WITH LOWER READINGS THAN THE TOTAL SERUM BILIRUBIN (TSB). NO ADVERSE PATIENT IMPACT WAS REPORTED. THE DEVICE WAS SENT TO TELFORD FOR ANALYSIS AND ACCORDING TO SERVICE NOTE ORDER (B)(4) THE METER PASSED THE PRE-INSPECTION TEST, AND THE TEST CHECKER READINGS WERE WITHIN TOLERANCE. THE ENGINEER RECALIBRATED THE DEVICE FOR CUSTOMER SATISFACTION AND ALL THE FUNCTIONS OF THE JM105 PASSED POST CALIBRATION, AND THE DEVICE WAS SENT BACK TO THE CUSTOMER. THE CUSTOMER PROVIDED PATIENT JAUNDICE METER READINGS AND BLOOD READINGS COMPARISON DATA ALONG WITH ANSWERS TO THE JM105 CLINICAL QUESTIONS. BASED ON THE INFORMATION GIVEN BY THE USER, CRITERIA FOR PROPER USE OF THE JM105 AND FOR PROCESSING THE BLOOD FOR TSB MEASUREMENTS WERE BEING MET. AN ANALYSIS OF THE DATA PROVIDED DID NOT RESULT IN A PRECISE ROOT CAUSE EXPLAINING THE VALUES THAT WERE NOT WITHIN THE 1.5 DEVIATION, WHICH DRAGER HAS DETERMINED THROUGH CLINICAL TRIALS TO BE ACCEPTABLE DEVIATIONS. BECAUSE THERE WAS NO MALFUNCTION FOUND WITH THE DEVICE AND ADDITIONAL TRAINING WITH THE USE OF THE JAUNDICE METER DOES NOT APPEAR TO BE NEEDED AT THIS TIME, AN EXACT ROOT CAUSE CANNOT BE DETERMINED. NO FURTHER ISSUES HAVE BEEN REPORTED WITH THIS DEVICE. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) THE JM105 JAUNDICE METER IS TO BE USED A SCREENING DEVICE IN CONJUNCTION WITH OTHER CLINICAL SIGNS AND LABORATORY MEASUREMENTS PRIOR TO MAKING TREATMENT DECISIONS.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE JAUNDICE METER (JM) 105 GAVE "MOSTLY" LOW READINGS. NO ADVERSE PATIENT IMPACT OR PATIENT DEATH WAS REPORTED.