MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CKL CREATINE KINASE; DIFFERENTIAL RATE KINETIC METHOD, CPK OR ISOENZYMES

Catalog Number ASKU

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

The customer consistently received questionable high troponin t hs, creatine kinase (ck), and elecsys ck-mb immunoassay results for one patient from the cobas 8000 cobas e 602 module serial number (b)(4).This medwatch is for creatine kinase.Refer to the "medwatchs" with patient identifiers (b)(6) and (b)(6) for the other assays.The doctor believed the result were an "implausible constellation of cardiac markers in case of a showing no cardiac symptoms".There was no evidence of an acute myocardial infarct.There was no allegation of an adverse event.The customer suspected a non-cardiac isoform of troponin t was present.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: CKL CREATINE KINASE
• Type of Device: DIFFERENTIAL RATE KINETIC METHOD, CPK OR ISOENZYMES
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8178968
• MDR Text Key: 131155645
• Report Number: 1823260-2018-05005
• Device Sequence Number: 1
• Product Code: JHS
• Combination Product (y/n): N
• PMA/PMN Number: K951595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 12/07/2018
• Supplement Dates FDA Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR