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

Catalog Number	03263991190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable cobas integra creatinine plus ver.2 assay results for 3 patient samples on a cobas integra 400 plus analyzer.Patient 1 the initial result was 1.73 mg/dl.The result was reported outside the laboratory.Another sample from the patient was tested at another laboratory.Due to the discrepancy between the results, the initial sample was retested.On (b)(6) 2024 the repeated result was 0.9 mg/dl.Patient 2: on (b)(6) 2024 the initial result was 1.48 mg/dl.On (b)(6) 2024 the repeated result was 0.9 mg/dl.Patient 3: on (b)(6) 2024 the initial result was 1.25 mg/dl and the repeated result was 0.73 mg/dl.
Additional Manufacturer Narrative
Qc and calibration data were inconspicuous.A general reagent issue was excluded.The field service representative replaced the wash syringe plunger seals and maintenance actions were performed.The customer used a draw volume of 3 ml instead of 5 ml for the tubes.No information regarding the tube manufacturer's specifications regarding clotting time could be provided.The investigation determined the issue was consistent with a pre-analytical handling issue.The investigation did not identify a product problem.

• Brand Name: COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
• 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: 19984299
• Report Number: 1823260-2024-02365
• Device Sequence Number: 4374404
• Product Code: JFY
• UDI-Device Identifier: 04015630919215
• UDI-Public: 04015630919215
• Combination Product (Y/N): Y
• Initial Reporter Country: LE
• 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): 10/18/2024

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: 03263991190
• Device Lot Number: 79448201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 10/18/2024
• 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