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

Catalog Number	07027583190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant low results for 3 patient samples tested for elecsys myoglobin (myo) on a cobas e 801 analytical unit.Patient 1 initial result was 21.0 ng/ml with a data flag.The repeat result from an e411 analyzer was 76.68 ng/ml.Patient 2 initial result was 21.0 ng/ml with a data flag.The repeat result from an e411 analyzer was 53.72 ng/ml.Patient 3 initial result was 21.0 ng/ml with a data flag.The repeat result from an e411 analyzer was 1260 ng/ml.The repeat result from the e801 analyzer was 1168 ng/ml.The initial results did not correspond to the patient¿s clinical condition.The repeat results were believed to be correct.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The e801 analyzer serial number was (b)(6).
Additional Manufacturer Narrative
No issues were observed with the calibration and qc data.The field service engineer (fse) found the software feature of the instrument that triggers specific alarms had been turned off.The investigation did not identify a product problem.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21275602
• Report Number: 1823260-2025-00291
• Device Sequence Number: 17050868
• 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): 02/17/2025

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: 09/30/2025
• Device Catalogue Number: 07027583190
• Device Lot Number: 79969401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 02/18/2025
• 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