MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS MYOGLOBIN; MYOGLOBIN ASSAY

Catalog Number	07027583190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys myoglobin on a cobas e 801 analytical unit.Two serum tubes were collected from the patient at the same time.The first serum tube resulted in a myoglobin value of 28.5 ng/ml the second tube resulted in a value of 388 ng/ml.An edta plasma tube collected at the same time resulted in a myoglobin value of 159 ng/ml.All tubes were repeated and all recovered the same values.
Additional Manufacturer Narrative
The serial number of the e 801 analyzer is: (b)(6).The patient's sample was provided for investigation.Initial investigations were able to reproduce the values obtained by the customer.The investigation is ongoing.
Additional Manufacturer Narrative
Further investigations of the patient's sample found no significant interference.The investigation could not identify a product problem.The cause of the event could not be determined.The issue is consistent with a local issue.Internal application data showed no difference between serum and 3 different plasma sample types.

• Brand Name: ELECSYS MYOGLOBIN
• Common Device Name: MYOGLOBIN ASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23597482
• Report Number: 1823260-2025-04731
• Device Sequence Number: 9381332
• Product Code: DDR
• UDI-Device Identifier: 04015630940059
• UDI-Public: 04015630940059
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K083260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: 07027583190
• Device Lot Number: 84460301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown