MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREATINE KINASE; CREATINE PHOSPHOKINASE/CREATINE KINASE OR ISOENZYMES TEST SYSTEM

Catalog Number 05168546190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The customer stated qc results were within the acceptable range.The customer stated this issue was only noticed with this patient sample.No other patient samples were affected.(b)(4).

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for creatine kinase-mb (ckmb) and creatine kinase (ck) on a cobas 8000 c 702 module compared to the ortho vitros and beckman methods.This medwatch will cover ck.Refer to medwatch with patient identifier (b)(6) for information on the ck-mb results.The roche results were reported outside of the laboratory.The cobas 8000 core unit serial number was (b)(4).The c702 module serial number was not provided.

Manufacturer Narrative

The customer has not provided any additional information for investigation.Based on the available data, both a general instrument and reagent issue have been excluded since the sample was repeated several times and the qc results were always acceptable.Since the customer only noticed the difference in results between the roche instrument and the ortho method with this 1 patient, it is likely the issue is related to this specific patient sample (e.G.An interferent).The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: CREATINE KINASE
• Type of Device: CREATINE PHOSPHOKINASE/CREATINE KINASE OR ISOENZYMES TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10123538
• MDR Text Key: 203676688
• Report Number: 1823260-2020-01369
• Device Sequence Number: 1
• Product Code: JHS
• Combination Product (y/n): N
• PMA/PMN Number: K160570
• 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: 10/21/2020

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 Expiration Date: 09/30/2020
• Device Catalogue Number: 05168546190
• Device Lot Number: 45203801
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/08/2020
• Initial Date FDA Received: 06/05/2020
• Supplement Dates Manufacturer Received: 05/08/2020
• Supplement Dates FDA Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1