MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREATININE PLUS VER.2; ENZYMATIC METHOD, CREATININE

Catalog Number	05168589190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas 8000 c702 module is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable crep2 (creatinine) result from one patient sample tested on the cobas 8000 c702 module.The initial result was not reported outside of the laboratory as it did not match the patient's clinical diagnosis.The reporter alleged the initial result from the module was low due to an interference with the patient's medication.On (b)(6) 2024: the initial result of the initial patient sample from the module was 372 umol/l.The first repeat result of the initial patient sample from a hitachi analyzer using a maccura reagent was 503 umol/l.The second repeat result of the initial patient sample from another facility was 458.2 umol/l.The repeat results were from assays which also use an enzymatic laboratory method.On (b)(6) 2024: a new patient sample was collected from the patient after his medication of 20ml of acetylcysteine (4g and 8g infusion pump) was discontinued.The initial result of the new patient sample from the module was 540 umol/l.The repeat result of the new patient sample using the maccura reagent was 548 umol/l.The reporter deemed these results consistent.
Additional Manufacturer Narrative
The investigation noted that the patient's creatinine plus ver.2 result was comparable with the other result when the patient's patient's acetylcysteine medication was discontinued.The investigation determined the event was consistent with an interference from the patient's acetylcysteine medication.Product labeling states "acetaminophen, acetylcysteine, and metamizole are metabolized quickly.Therefore, interference from these substances is unlikely but cannot be excluded." the investigation did not identify a product problem.

• Brand Name: CREATININE PLUS VER.2
• Common Device Name: ENZYMATIC METHOD, CREATININE
• 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: 19684263
• Report Number: 1823260-2024-01948
• Device Sequence Number: 20545787
• Product Code: JFY
• UDI-Device Identifier: 04015630924998
• UDI-Public: 04015630924998
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K024098
• 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): 10/25/2024

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: 05168589190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 10/25/2024
• 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: 20ML OF ACETYLCYSTEINE (4G AND 8G INFUSION PUMP).
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic