Drager Jaundice Meter, model JM-105 MU20105Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04049098000246), received between Mar 3, 2017 and Mar 6, 2025 — classified as 1 death, 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Low Readings” (18 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2025Low Readings; Low Readings

  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.

  Patient problems: Jaundice

  MAUDE report 21540558 ↗
• MalfunctionFeb 21, 2025Low Readings; Low Readings

  THE CUSTOMER REPORTED THE READINGS OF THE JAUNDICE METER READS OUTSIDE SPECIFICATION, STANDARD ACCEPTABLE LEVEL OF ERROR FOR THE DRAGER IS +/- 1.5 POINTS 66% OF THE TIME WHEN COMPARED TO SERUM BILIRUBIN. 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. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.

  Patient problems: Jaundice

  MAUDE report 21437351 ↗
• MalfunctionOct 18, 2024Low Readings; Low Readings

  IT WAS REPORTED THAT THE JAUNDICE METER, JM105, WAS ONE MONTH OVERDUE FOR CALIBRATION. THE CUSTOMER NOTICED THAT THE METER WAS GIVING LOW READINGS. FOR EXAMPLE, WHEN THE PATIENT'S SERUM BILIRUBIN (SBR) WAS 300, THE METER WOULD GIVE A READING OF 90. THE LOW READINGS WERE FOUND AFTER IT WAS USED ON A FEW PATIENTS, AND IT WAS AT THAT POINT THAT THE CUSTOMER CHECKED THE METER AND REALIZED IT NEEDED CALIBRATION. THE DEVICE WAS TAKEN OUT OF CLINICAL USE AND SENT TO DRAEGER FOR CALIBRATION. IT WAS STATED THAT THE CUSTOMER ALWAYS KEPT THE METER ON THE DOCKING STATION AND THE NURSE CHECKED THE DEVICE'S CHARGE ONCE A DAY.

  Patient problems: Jaundice

  MAUDE report 20483018 ↗
• MalfunctionOct 10, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE JAUNDICE METER 105, JM-105, GAVE LOW READINGS WHEN USED BY THE CUSTOMER AND COMPARED TO THE BLOOD BILIRUBIN LAB SAMPLES. THE CUSTOMER STATED THEY TESTED THE DEVICE AND COLLECTED 35 DATA SAMPLES TO COMPARE THE JM105 MEASUREMENTS TO THE LAB SAMPLE RESULTS. THE TOTAL MEASUREMENTS THAT WERE WITHIN RANGE WAS 16/35 OR 46%. THE TOTAL MEASUREMENTS THAT WERE OUT OF RANGE WAS 19/35 OR 54%. THE CUSTOMER'S JM-105 WAS UNDER WARRANTY, SO IT WAS REPLACED. THERE WAS NO REPORT OF PATIENT INJURY OR DEATH.

  Patient problems: Insufficient Information; Jaundice

  MAUDE report 20418960 ↗
• MalfunctionOct 9, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE JAUNDICE METER - 105, JM-105, WAS PRODUCING INCONSISTENT READINGS WHEN USED BY THE CUSTOMER. THE CUSTOMER COLLECTED 25 DATA POINTS WHERE THE JM-105 WAS USED TO GET BILIRUBIN READINGS AND COMPARED THEM TO THE BLOOD BILIRUBIN LAB RESULTS. THE RESULTS SHOWED SOME OF THE JM-105 RESULTS WERE CLOSE AND SOME WERE FURTHER OFF FROM THE BLOOD BILIRUBIN LAB RESULT. THESE MEASUREMENTS WERE INCONSISTENTLY OFF AS SOME WERE HIGHER AND SOME WERE LOWER THAN THE ACTUAL RESULTS FROM THE LAB TESTS. THE CUSTOMER STATED THAT THE DEVICE WAS CALIBRATED DAILY, MONDAY THROUGH FRIDAY. ADDITIONALLY, THE CUSTOMER CONFIRMED THAT THE METER MEASUREMENTS WERE TAKEN AT THE PATIENT'S STERNUM, THE DATA POINTS WERE AVERAGES OF MULTIPLE MEASUREMENTS, THAT THE PROBE WAS USED AT THE CORRECT POSITIONING ON THE SKIN, THAT THAT THE PATIENT'S HOURS OF LIFE WERE TAKEN INTO CONSIDERATION AT THE TIME OF MEASUREMENT, THAT THE LAB EQUIPMENT THAT USED TO TEST THE BLOOD SAMPLES WAS CALIBRATED, AND THEY CONFIRMED THAT THE BLOOD SAMPLES WERE TAKEN AT THE SAME TIME AS THE METER MEASUREMENTS. THE UNIT WAS TAKEN OUT OF USE FOR INVESTIGATION AND THE CUSTOMER WAS PROVIDED WITH A BRIDGE UNIT TO USE IN REPLACEMENT.

  Patient problems: Insufficient Information; Jaundice

  MAUDE report 20409960 ↗
• MalfunctionSep 18, 2024Low Readings; Low Readings

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

  Patient problems: Insufficient Information; Jaundice

  MAUDE report 20247746 ↗
• MalfunctionSep 18, 2024Low Readings; Low Readings

  THE CUSTOMER REPORTED A JAUNDICE METER 105 THAT HAD BOTH LOW AND HIGH READINGS. THE METER HAD BEEN IN USE A FEW MONTHS. THE CUSTOMER STATED THAT THE TCB READINGS HAVE BEEN LOWER THAN THE SERUM RESULTS BY 3-4 POINTS WITH A COUPLE RESULTS GREATER THAN THAT, AND THAT THE STAFF WOULD HAVE CHANGED TREATMENT IF THE USERS HAD NOT COLLECTED SERUM. THE STAFF REPORTEDLY CALIBRATE THE UNIT BEFORE EVERY USE. NO ADVERSE PATIENT IMPACT OR DEATH WAS REPORTED.

  Patient problems: Insufficient Information; Jaundice

  MAUDE report 20246069 ↗
• MalfunctionSep 18, 2024Low Readings; Low Readings

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

  Patient problems: Insufficient Information; Jaundice

  MAUDE report 20246056 ↗
• MalfunctionJul 29, 2024Low Readings; Low Readings

  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.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19855786 ↗
• MalfunctionJun 21, 2024Low Readings; No Apparent Adverse Event; Low Readings; No Apparent Adverse Event

  THE CUSTOMER REPORTED THAT A JAUNDICE METER READS OUTSIDE OF THE TOLERANCE 1.5, + OR - AT LEAST 66% OF THE TIME WHEN COMPARED TO SERUM BILIRUBIN. THERE WAS NO REPORT OF A PATIENT INJURY OR DEATH.

  Patient problems: Jaundice

  MAUDE report 19581977 ↗
• MalfunctionJun 21, 2024Low Readings; No Apparent Adverse Event; Low Readings; No Apparent Adverse Event

  THE CUSTOMER REPORTED THAT A JAUNDICE METER READS OUTSIDE OF THE TOLERANCE 1.5, + OR - AT LEAST 66% OF THE TIME WHEN COMPARED TO SERUM BILIRUBIN. THERE WAS NO REPORT OF A PATIENT INJURY OR DEATH.

  Patient problems: Jaundice

  MAUDE report 19580978 ↗
• MalfunctionJun 21, 2024Low Readings; No Apparent Adverse Event; Low Readings; No Apparent Adverse Event

  THE CUSTOMER REPORTED THAT A JAUNDICE METER READS OUTSIDE OF THE TOLERANCE 1.5, + OR - AT LEAST 66% OF THE TIME WHEN COMPARED TO SERUM BILIRUBIN. THERE WAS NO REPORT OF A PATIENT INJURY OR DEATH.

  Patient problems: Jaundice

  MAUDE report 19580587 ↗
• MalfunctionApr 29, 2024Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT A JAUNDICE METER HAD MULTIPLE LOW READINGS WHEN COMPARED TO THE TSB. ADDITIONAL INFORMATION REGARDING THE LOW READINGS, PATIENT AGE AND CONDITIONS WAS REQUESTED. NO PATIENT INJURY OR DEATH WAS REPORTED.

  Patient problems: Jaundice

  MAUDE report 19203890 ↗
• MalfunctionApr 29, 2024Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT THE JM 105 HAD LOW READINGS WHEN COMPARED TO TSB READINGS THROUGHOUT THE MONTH OF MARCH. NO PATIENT INJURY OR DEATH WAS REPORTED.

  Patient problems: Jaundice

  MAUDE report 19203808 ↗
• MalfunctionFeb 27, 2024Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THAT THE DRAEGER JM105 METER READINGS ARE LOWER THAN COMPARED TO THE SERUM. THE CUSTOMER DID A VALUE COMPARISON TO THE METER THAT WAS IN USE AND AN DIFFERENT METER. IT WAS NOTED THAT THERE WAS AN AVERAGE OF -2.79 DIFFERENCE BETWEEN THE 2 METERS AND A -3.21 DIFFERENCE WITH THE METER IN QUESTION VS. THE TECHNICAL SERVICE BULLETIN (TSB). THERE WAS NO REPORTED ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18791616 ↗
• MalfunctionFeb 26, 2024Low Readings; Low Readings

  IT WAS REPORTED THAT THE JM105 PROVIDED LOW VALUES. NO ADVERSE PATIENT IMPACT WAS REPORTED.

  Patient problems: Jaundice

  MAUDE report 18777815 ↗
• MalfunctionAug 18, 2023Low Readings; Low Readings

  IT WAS REPORTED THAT THE DRAEGER JM105 JAUNDICE METER WAS READING LOWER THAN BLOOD SERUM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17577206 ↗
• MalfunctionAug 14, 2023Low Readings; Low Readings

  IT WAS REPORTED THAT THE DRAEGER JM105 JAUNDICE METER WAS PROVIDING INCONSISTENT/LOW READINGS. NO ADVERSE PATIENT IMPACT WAS REPORTED.

  Patient problems: Jaundice

  MAUDE report 17546187 ↗
• MalfunctionJul 20, 2023Low Readings; Low Readings

  IT WAS REPORTED THAT THE DRAEGER JM105 JAUNDICE METER WAS PROVIDING INCONSISTENT/LOW READINGS. NO ADVERSE PATIENT IMPACT WAS REPORTED.

  Patient problems: Jaundice

  MAUDE report 17367686 ↗
• MalfunctionJul 17, 2023Low Readings; Low Readings

  IT WAS REPORTED THAT THE JM105 JAUNDICE METER WAS MEASURING INCORRECTLY, THE READING WERE LOWER THAN EXPECTED. NO ADVERSE PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17332528 ↗
• DeathJul 7, 2023Non Reproducible Results; Non Reproducible Results

  THE FOLLOWING WAS REPORTED: "NEWBORN YOUNG THAT APPEAR YELLOW. WAS MEASURED WITH THE EQUIPMENT THAT IS REPORTED HERE SEVERAL TIMES AS SHOWING 0 IN THE DISPLAY. THIS IS MISINTERPRETED AS IF THE VALUE IS LOW AND MAY HAVE CONTRIBUTED TO THE CHILD GETTING WORSE AND DYING DURING TRANSFER TO ANOTHER HOSPITAL. THE DEATH HAS BEEN REPORTED IMMEDIATELY TO THE NORWEGIAN HEALTH AUTHORITY. THIS MESSAGE ONLY APPLIES TO THE EQUIPMENT. IN THE EVENT ANALYSIS, IT IS FOUND THAT THE DEVICE SHOWS ZERO, WHEN THE VALUES ARE ABOVE THE MEASURABLE VALUE RANGE. THE MANUFACTURER HAS PASTED A SMALL NOTE ON THE DEVICE WARNING OF THIS, BUT THE NOTE IS ALMOST TOO SMALL TO BE READ. THE UNDERSIGNED CANNOT SEE THAT THIS IS NOTIFIED IN THE PRODUCT INFORMATION AVAILABLE ONLINE. IT IS HEREBY NOTIFIED THAT IT IS EASY TO MISINTERPRET THE DISPLAY ON A DEVICE THAT IS IN USE IN NORWEGIAN MATERNITY WARDS."

  Patient problems: Jaundice

  MAUDE report 17277772 ↗
• MalfunctionMay 15, 2023Low Readings; Low Readings

  IT WAS REPORTED THAT THE CUSTOMER HAS CONSISTENTLY NOTED A DIFFERENCE IN A JM-105 JAUNDICE METERS READINGS OF 6 TO 7MG/DL LOWER FROM SERUM ON TWO DIFFERENT LABORATORY DEVICES. NO ADVERSE PATIENT IMPACT WAS REPORTED.

  Patient problems: Jaundice

  MAUDE report 16935838 ↗
• InjuryMar 3, 2017High Test Results; Device Displays Incorrect Message

  THE METER JM-105 SHOWED FLASHING -0- WHICH WAS INTERPRETED BY THE USER AS A BILIRUBIN VALUE OF 0. THE PATIENT WAS SENT HOME WITHOUT A FOLLOW-UP SERUM BLOOD TEST FOR BILIRUBIN & RETURNED TO THE HOSPITAL AFTER 2 DAYS WITH A BILIRUBIN VALUE OF OVER 600 MMOL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6376480 ↗