MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREATININE JAFFÉ GEN. 2; ALKALINE PICRATE, COLORIMETRY, CREATININE

Catalog Number	06407137190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
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 crej2 creatinine jaffé gen.2 (crej2) result from one patient sample tested on the cobas 8000 c702 module.On (b)(6) 2024: the initial result of the initial patient sample was 8.12 mg/dl.This result did not fit the patient's history prompting the collection of a new patient sample and the rerun of the initial patient sample.On (b)(6) 2024: the result of a new patient sample was 0.87 mg/dl.This result was deemed correct.The repeat result of the initial patient sample was 7.97 mg/dl.The initial result was not reported outside the laboratory.
Additional Manufacturer Narrative
The field service engineer inspected the module and verified the probe, gear pump, and rinse unit were all working according to specifications.The investigation reviewed the calibration data, alarm trace, and precision checks and the results were according to specifications.The customer stated that the samples were most likely mixed up and did not belong to the same patient.The investigation determined the patient sample mix-up had caused the event.The investigation did not identify a product problem.

• Brand Name: CREATININE JAFFÉ GEN. 2
• Common Device Name: ALKALINE PICRATE, COLORIMETRY, 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: 20305021
• Report Number: 1823260-2024-02769
• Device Sequence Number: 7624053
• Product Code: CGX
• UDI-Device Identifier: 04015630930777
• UDI-Public: 04015630930777
• 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): 11/21/2024

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: 07/31/2025
• Device Catalogue Number: 06407137190
• Device Lot Number: 75538101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 11/21/2024
• 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