MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CKMBL CREATINE KINASE-MB; CPK OR ISOENZYMES

Catalog Number	07190794190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable ckmbl creatine kinase-mb results from the cobas integra 400 plus w/o ise analyzer.The initial result was 6655 ul/l.The repeat result was 6569 ul/l and after calibration, the repeat result was 82 ui/l.On (b)(6) 2024, the repeat result was 7360 ui/l.After another calibration and cleaning of the inner and outer water tank, the repeat result was 5784 ui/l.For this test, the customer used a different edta sample from the same venipuncture.The result of 82 ui/l was reported outside of the laboratory.
Additional Manufacturer Narrative
The analyzer serial number was (b)(6).A general reagent problem was ruled out because calibration and quality control were acceptable.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The specific cause of the event could not be determined based on the provided information.A general reagent problem was ruled out because calibration and quality control were acceptable.Analyzer alarms received by the customer indicated overfilled tubes or wrong tube configuration, which both potentially lead to a too-deep dive of the probe into the sample, which could then cause additional droplets at the outer side of the probe.

• Brand Name: CKMBL CREATINE KINASE-MB
• Common Device Name: CPK OR ISOENZYMES
• 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: 20148726
• Report Number: 1823260-2024-02568
• Device Sequence Number: 8259103
• Product Code: JHS
• UDI-Device Identifier: 04015630940806
• UDI-Public: 04015630940806
• Combination Product (Y/N): Y
• Initial Reporter Country: EG
• PMA/510(K) Number: K951595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

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 Expiration Date: 10/31/2024
• Device Catalogue Number: 07190794190
• Device Lot Number: 779827
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown