JAUNDICE JM105
Received Sep 18, 2024
Report 2510954-2024-00039 · MDR key 20246056
Device
Generic name
Jaundice Meter/bilirubinometer
Manufacturer
Draeger Medical Systems, Inc.Catalog number
MU20105
Product problems
- Low Readings
- Low Readings
Patient
NA · Unknown
- Jaundice
- Insufficient Information
- Jaundice
- Insufficient Information
Narrative
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.
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 CUSTOMER PROVIDED PATIENT JAUNDICE METER READINGS AND BLOOD READINGS COMPARISON DATA ALONG WITH ANSWERS TO THE JM105 CLINICAL QUESTIONS. AN ANALYSIS OF THE DATA SHOWED OUT OF THE 23 ELIGIBLE CHECKS, 8 WERE FOUND TO BE WITHIN THE DRAEGER STANDARD DEVIATION OF PLUS OR MINUS 1.5 AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). THE IFU FURTHER STATES THAT BASED ON THE AVERAGE OF CLINICAL DATA AVAILABLE, 66% OF THE VALUES TAKEN WITH THE JM105 SHOULD FALL WITHIN THE STANDARD DEVIATION RANGE. THE ELIGIBLE READINGS THAT WERE PROVIDED WOULD INDICATE A 32% PASS RATE HOWEVER, SOME OF THE CLINICAL DATA SUCH AS HOURS OF LIFE AND SKIN TYPE OF SOME OF THE PATIENTS WAS MISSING. IN ADDITION, SEVERAL REQUESTS WERE MADE TO DETERMINE IF THE CUSTOMER WAS PROCESSING THE TSB IN THE LAB WITHIN THE 1HOUR TIMEFRAME, BUT THIS INFORMATION WAS NOT MADE AVAILABLE. THE DEVICE WAS SENT TO TELFORD