MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CK-MB; CPK OR ISOENZYMES, COLORIMETRIC METHOD

Catalog Number	07027087190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable ck-mb elecsys e2g result from an unknown roche analyzer.There was an allegation that macro-ck was intermittently detected.Refer to the attachment to the medwatch for all patient data.The questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
Sample from the patient was submitted for investigation and the customer's results were reproduced.
Additional Manufacturer Narrative
Sample from the patient was investigated further.The sample was treated with heterophilic blocking tube (hbt) with scantibodies.No heterophilic antibodies were identified in the sample.The customer's results were reproduced.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation tested the patient sample for elecsys tsh to rule out a general elecsys interference.The tsh result indicated that the patient has no known thyroid disease.Therefore, a general elecsys interference can be ruled out.The investigation performed serum fractionation by (b)(6).There was no igg or igm interference detected.The investigation did not identify a product problem.The cause of the event could not be determined. .

• Brand Name: ELECSYS CK-MB
• Common Device Name: CPK OR ISOENZYMES, COLORIMETRIC METHOD
• 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: 17073474
• Report Number: 1823260-2023-01879
• Device Sequence Number: 6130222
• Product Code: JHY
• UDI-Device Identifier: 04015630939978
• UDI-Public: 04015630939978
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/14/2023

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 Catalogue Number: 07027087190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 07/04/2023; 08/02/2023; 10/23/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 07/17/2023; 08/11/2023; 11/14/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PRAVASTATIN; REPATHA
• Patient Age: 76 YR
• Patient Sex: Male