MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATTELLICA ACETAMINOPHEN; COLORIMETRY, ACETAMINOPHEN

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Other  

Event Description

I am the medical director of the (b)(6) and would like to report an issue with acetaminophen units reported by the siemen¿s attellica analyzer.The default reporting units for acetaminophen concentration reported by the analyzer is mg/dl.The treatment decision tool for acute acetaminophen overdoses is the rumack-matthew nomogram and it uses mcg/ml for the units.Https://emedicine.Medscape.Com/article/820200-workup#c8.Having non-standard units as the default units creates a systemic error where patients can be injured because units reported in mg/dl will not match up with the units in the treatment decision tool.To date, i am aware of 5 hospitals in (b)(6) with this issue in the past 12-16 months ¿ 3 of the hospitals have adjusted the interface to the emr so that reporting is now in standard units.I notified the siemens representative for the region last year of this patient quality issue, but since then 3 additional hospitals implemented the analyzer with the non-standard default units.Is it possible that the fda can require siemens to report acetaminophen concentrations in the same units as the treatment decision tool? reporting acetaminophen concentration in mcg/ml is the us and global standard.I am aware of one liver injury to date in il due to treatment error created by the default reporting units used by the siemens atellica analyzer.

• Brand Name: ATTELLICA ACETAMINOPHEN
• Type of Device: COLORIMETRY, ACETAMINOPHEN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.
• MDR Report Key: 18826050
• MDR Text Key: 336918834
• Report Number: MW5152256
• Device Sequence Number: 1
• Product Code: LDP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2024
• Patient Sequence Number: 1