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

Catalog Number 08057460190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458); Material Integrity Problem (2978)

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

Event Date 02/05/2024

Event Type  malfunction  

Manufacturer Narrative

The serial number of the customer's cobas pure c 303 analytical unit is (b)(6).The investigation is ongoing.

Event Description

The initial reporter received a questionable creatine kinase result from one patient sample tested on the cobas pure c 303 analytical unit.The initial result was not reported outside of the laboratory.The initial result at 5:33 was 16.5 u/l.The repeat result at 5:49 was 1180 u/l.The repeat result was deemed correct due to the patient history.

Manufacturer Narrative

The customer stated that the issue was resolved after they cleaned the sample probe.Based on the information provided, the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: CREATINE KINASE
• Type of Device: CPK, DIFFERENTIAL RATE KINETIC METHOD
• 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: 18776527
• MDR Text Key: 336884979
• Report Number: 1823260-2024-00539
• Device Sequence Number: 1
• Product Code: JHS
• Combination Product (y/n): Y
• Reporter Country Code: EG
• PMA/PMN Number: K160570
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 08057460190
• Device Lot Number: 744192
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• 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