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

Catalog Number	05168546190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c702 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with ck on a cobas 8000 c702 module.The customer alleges that the results may indicate there is an interferent in the sample that reacts with the assay.The sample initially resulted in a ck value of 1026 iu/l accompanied by a data flag indicating the reaction limit was exceeded.The sample repeated with a ck value of > 34041 iu/l accompanied by a data flag.The sample was diluted x20 and repeated twice on a second analyzer, resulting in ck values of 22 iu/l and 30 iu/l.The sample was tested again without dilution on the complained analyzer, resulting in a ck value of 30 iu/l.The sample was diluted again using an unknown dilution factor and repeated on an unknown analyzer, resulting in a ck value of 30 iu/l.
Additional Manufacturer Narrative
Calibration and control data were within specifications.A general reagent or system related issue can be excluded.The investigation determined the issue is consistent with insufficient pre-analytic sample handling.
Additional Manufacturer Narrative
Additional results were provided for the patient: (b)(6) 2023: 26 iu/l (1:20 dilution), no results with sample clot alarm, 1026 iu/l with data flag, 32023 iu/l (1:20 dilution), 30990 iu/l (decreased sample volume dilution), 2208 iu/l, 31973 (1:20 dilution), 31092 iu/l (decreased sample volume dilution), 30912 (1:10 dilution), 30556 iu/l (decreased sample volume dilution), and 1695 iu/l.

• Brand Name: CK
• Common Device Name: CREATINE PHOSPHOKINASE/CREATINE KINASE OR ISOENZYMES TEST SYSTEM
• 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: 18293647
• Report Number: 1823260-2023-03907
• Device Sequence Number: 20337097
• Product Code: JHS
• UDI-Device Identifier: 04015630924974
• UDI-Public: 04015630924974
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: K160570
• 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,Followup
• Report Date (Section B): 01/31/2024

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 Catalogue Number: 05168546190
• Device Lot Number: 736319
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 12/14/2023; 01/29/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 01/04/2024; 01/31/2024
• 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