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

Catalog Number	07027583190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys myoglobin (myo) results from five patient samples tested on the cobas e 801 analytical unit.The following are examples of discrepant results: patient sample 1: the initial result from the analyzer was <21 ng/ml.The repeat result from a cobas e 411 analyzer was 256.7 ng/ml.Patient sample 2: the initial result from the analyzer was <21 ng/ml.The repeat result from a cobas e 411 analyzer was 131.6 ng/ml.Patient sample 3: the initial result from the analyzer was <21 ng/ml.The repeat result from a cobas e 411 analyzer was 148.6 ng/ml.Patient sample 4: the initial result from the analyzer was <21 ng/ml.The repeat result from a cobas e 411 analyzer was 281.7 ng/ml.The initial results were not reported outside of the laboratory, as the results did not match the patients' clinical diagnoses.
Additional Manufacturer Narrative
The field service engineer (fse) inspected the analyzer and found no issues.The event's cause could not be determined based on the information provided.

• 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: 22009295
• Report Number: 1823260-2025-01475
• Device Sequence Number: 12101197
• 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): 06/02/2025

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 Catalogue Number: 07027583190
• Device Lot Number: 799694
• 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: 04/19/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/02/2025
• 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