MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CK-MB

Catalog Number 07190808190

Device Problems High Test Results (2457); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/26/2022

Event Type  malfunction  

Manufacturer Narrative

The cygnus auto ck-mb mto method has an ingredient that inhibits mitochondrial ck, while the roche cm-mb reagent does not.

Event Description

The initial reporter stated they received discrepant results for two samples from the same patient tested with ckmbl creatine kinase-mb on a cobas pro c503 analytical unit.Results are higher compared to ck-mb results measured on a cobas 8000 c 702 module with a third party method, ck-mb mto cygnus auto.The sample results were reported outside of the laboratory.The specific date of the event is not known.No units of measure were provided.On an unknown date, a first sample from the patient was initially tested using the roche ck-mb method on a c 503 system, resulting in a value of 18.The sample was repeated on the c702 analyzer using the cygnus auto ck-mb mto method, resulting in a value of 9.On (b)(6) 2022, a second sample from the patient was initially tested using the roche ck-mb method on a c 503 system, resulting in a value of 31.The clinician questioned the initial result.The sample was repeated on the c702 analyzer using the cygnus auto ck-mb mto method on (b)(6) 2022, resulting in a value of 8.The serial number of the c503 analyzer is (b)(4).The serial number of the (b)(4) analyzer was requested, but not provided.

Manufacturer Narrative

Calibration and control results were good.There is no indication of an issue related to a roche product.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: CK-MB
• Type of Device: CK-MB
• 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: 15055467
• MDR Text Key: 304434130
• Report Number: 1823260-2022-02142
• Device Sequence Number: 1
• Product Code: JHS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K951595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07190808190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1