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	03/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e801 analyzer serial number was (b)(6).
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.For all 3 patient samples, the initial result was < 21.0 ng/ml with a data flag.Patient 1 repeat result was 66.4 ng/ml.Patient 2 repeat result was 350 ng/ml."patient 5" repeat result was 281 ng/ml.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
Qc was acceptable.Upon review of the alarm trace data, multiple sample clot alarms were observed.The customer used a clotting time of 30 minutes.This clotting time may be too short.Based on the information provided, the cause of the event could not be determined.The investigation determined the event was consistent with a preanalytical handling issue.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: 19089425
• Report Number: 1823260-2024-01125
• Device Sequence Number: 15408791
• Product Code: DDR
• UDI-Device Identifier: 04015630940059
• UDI-Public: 04015630940059
• Combination Product (Y/N): Y
• 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): 05/15/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Catalogue Number: 07027583190
• Device Lot Number: 741940
• 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: 03/22/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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