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

Catalog Number	05168546190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Renal Failure (2041)
Date of Event	11/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The serial number of the c702 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter alleged there was a discrepant result for one patient sample tested with ck on a cobas 8000 c702 module which led to a delay in the patient receiving the correct diagnosis and the appropriate treatment.The patient reportedly presented to the hospital with whole-body aches, specifically in the abdomen, reduced sensation and strength in one leg, and vomiting.The patient reportedly fell a few days before admission.The patient reportedly had a creatinine value of approximately 400 umol/l and was allegedly in renal failure at the time of admission.The sample was reportedly collected from the patient at the time the patient was admitted to the hospital.The sample reportedly had low volume, so the analysis was performed with the sample placed into a micro-cup on top of a sample tube.The sample initially resulted in a ck value of 414.2 u/l.The patient was allegedly incorrectly diagnosed with cold sepsis due to the value.A second sample collected from the patient on (b)(6) 2023 resulted in a ck value of 99843 u/l, so the low value from the first sample was questioned by the physician.The sample was repeated on (b)(6) 2023, resulting in a ck value of - 305.3 u/l.The sample was diluted 1:50 and repeated on (b)(6) 2023, resulting in a ck value of 173993 u/l.There was reportedly a delay in the patient receiving a correct diagnosis of rhabdomyolysis due to aseptic necrosis following musculoskeletal ischemia likely following a fall.The patient's treatment with forced alkaline diuresis and surgical treatment was reportedly delayed.
Additional Manufacturer Narrative
Calibration and qc data were acceptable.A general reagent issue can be excluded.Medwatch field d4 has been updated.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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: 18304186
• Report Number: 1823260-2023-03927
• Device Sequence Number: 17822135
• Product Code: JHS
• UDI-Device Identifier: 04015630924974
• UDI-Public: 04015630924974
• Combination Product (Y/N): Y
• Initial Reporter Country: NO
• 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
• Report Date (Section B): 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 05168546190
• Device Lot Number: 73631901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 01/24/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CALCIUM ANTAGONIST; PROTON PUMP INHIBITOR; VENTOLINE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male