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

Catalog Number	07027583190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient sample was received for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received questionable results for one patient sample tested with the elecsys troponin t hs on a cobas e 801 module (serial number (b)(4)).The troponin t hs results did not agree with the clinical examination and history of the patient and the customer suspects an interference-based discrepant high elecys troponin t hs result.The patient sample also generated questionable elecsys myoglobin results, which were not taken into consideration since the elecsys troponin t values were already considered implausible.This medwatch will apply to the elecsys myoglobin assay.Please refer to the medwatch with patient identifier.Patient identifier (b)(6) for information related to the elecsys troponin t hs assay.The sample initially resulted in a myoglobin value of 53.1 ng/ml.The sample was diluted 10 times and repeated, resulting in a value of <210 ng/ml, accompanied by a data flag.The sample was then repeated undiluted, resulting in a value of 21.0 ng/ml, accompanied by a data flag.The questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
Upon initial investigation of the patient sample, the customer's results could be reproduced.The patient sample resulted in a troponin t hs value of 275 pg/ml, a myoglobin value of 57 ng/ml, and a ck-mb value of 7.38 ng/ml.The investigation is ongoing.
Additional Manufacturer Narrative
A general reagent issue can be excluded.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15923282
• Report Number: 1823260-2022-03887
• Device Sequence Number: 5209885
• Product Code: DDR
• UDI-Device Identifier: 04015630940059
• UDI-Public: 04015630940059
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 01/16/2023

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: 10/31/2023
• Device Catalogue Number: 07027583190
• Device Lot Number: 636130
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2022
• Supplement Date Received by Manufacturer: 12/01/2022; 12/21/2022
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 12/20/2022; 01/16/2023
• 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 Age: 64 YR
• Patient Sex: Female