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

Catalog Number	07027583190
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the cobas e 801 analytical unit is (b)(6).The serial number of the cobas c 503 analytical unit was requested but not provided.The patient samples were requested for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys myoglobin (myo) results from five patient samples (three from the same patient) tested on the cobas e 801 analytical unit and the cobas c 503 analytical unit.This medwatch is for the elecsys myoglobin (myo) assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for the tina-quant myoglobin gen.2 test system assay.Patient sample 1a on (b)(6) 2024: the initial result of the undiluted patient sample from the analyzer was <21 ug/l.This result did not correspond with the ck result of 53.9 ukat/l with a data flag (undiluted) and 55.9 ukat/l (with dilution) prompting the dilution of the patient sample.The first repeat result at 10x dilution from the analyzer was 210 ug/l with a data flag.The second repeat result at 20x dilution from the analyzer was 420 ug/l with a data flag.The third repeat result at 100x dilution from the analyzer was 2393 ug/l.The repeat result at 900x dilution from the analyzer was > 20,000 ug/l the result from the other laboratory that uses the chemiluminescence immunoassay (clia) method was 59.7 ng/ml.This result corresponds with the patient¿s ck-mb result.The repeat result from the cobas c 503 was 77 ug/l.Patient sample 1b on (b)(6) 2024: the initial result of the undiluted patient sample from the analyzer was 21.0 ug/l with a data flag.The repeat result with the patient sample at an unknown dilution from the analyzer was 2444 ug/l.The repeat result at 100x dilution from the analyzer was 2300 ug/l the repeat result at 900x dilution from the analyzer was > 20,000 ug/l the repeat result from the other laboratory that uses clia method was 31.6 ng/ml the repeat result from the cobas c 503 was 47.1 ug/l.Patient sample 1a or 1b (unspecified) on (b)(6) 2024: the repeat result at 1:400 dilution was 9545 ug/l.The repeat result at 1:900 dilution was 21920 ug/l.The repeat result of the undiluted patient sample was <21 ug/l.The repeat result at 1:100 dilution was 2339 ug/l.Patient sample 1a or 1b (unspecified) on (b)(6) 2024: the result from another laboratory's e 801 analyzer was the same as the result from the analyzer.Patient sample 1c on (b)(6) 2024.The initial result of the undiluted patient sample from the analyzer was <21 ug/l.The repeat result at 100x dilution from the analyzer was approximately 2300 ug/l.The repeat result at 900x dilution from the analyzer was > 20,000 ug/l.The repeat result from the other laboratory that uses clia method was 30.8 ng/ml.The repeat result from the cobas c 503 was 48.8 ug/l.Patient sample 2 the initial result of the undiluted patient sample from the analyzer was >3000 ug/l.The first repeat result with the patient sample at an unknown dilution from the analyzer was > 26,000 ug/l.The second repeat result from another laboratory that uses the clia method was 6902 ng/ml.The third repeat result from the cobas c 503 was 1099 ug/l with a data flag.The fourth repeat result from the cobas c 503 was 17,412 ug/l with a data flag.Patient sample 3 the initial result of the undiluted patient sample from the analyzer was 1414 ug/l the first repeat result at 100x dilution from the analyzer was > 10,000 ug/l.The second result at 900x from the analyzer dilution was >27,000.
Additional Manufacturer Narrative
Patient sample 1b, patient sample 1 with a labeled date of (b)(6) 2024, and patient sample 3 were received for investigation.The patient samples were tested for elecsys myoglobin.The investigation confirmed the customer's undiluted patient sample results.The results of the patient samples at 1:100 and 1:1500 dilution factor were below 50 ng/ml.The investigation tested patient 1's samples for myoglobin (clinchem) assay and the results were in the low range of a healthy person.The investigation again tested patient sample 3.The result of the undiluted patient sample was 1466 ng/ml and the result at 1:3 dilution factor was 1515 ng/ml with 103.3% dilution recovery.The investigation determined the event was caused by the customer's dilution of a negative patient sample.Product labeling states "dilution samples with myoglobin concentrations above the measuring range can be diluted with diluent universal.The concentration of the diluted sample must be >50 ng/ml." 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: 19715176
• Report Number: 1823260-2024-01980
• Device Sequence Number: 8514130
• Product Code: DDR
• UDI-Device Identifier: 04015630940059
• UDI-Public: 04015630940059
• Combination Product (Y/N): Y
• Initial Reporter Country: EZ
• 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): 10/02/2024

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 Catalogue Number: 07027583190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 10/02/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE REFER TO THE ATTACHMENT (B)(6).
• Patient Sex: Unknown