MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREJ2; ALKALINE PICRATE, COLORIMETRY, CREATININE

Model Number	CREAJ
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No issues were identified during a review of the reaction monitor data.Calibration was last performed on (b)(6) 2022 with acceptable results.It was noted that the calibration from (b)(6) 2022 initially showed an error; upon repeating calibration on (b)(6) 2022 the results were acceptable.At the time of the calibration error on (b)(6) 2022, qc failed.Qc on the day of the event was acceptable.No issues were identified during a review of the alarm trace data.The investigation determined the initial and repeat results were performed with different reagent cassettes from the same lot number.The reagent cassette used for the initial results had been flagged with the calibration error on (b)(6) 2022 and was successfully calibrated on the same day.The repeat results were performed with a different reagent cassette.The investigation determined the event was consistent with an issue with the reagent cassette used for the initial results (e.G.Storage, handling conditions), however, the specific root cause could not be determined.The investigation did not identify a product problem.
Event or Problem Description
The initial reporter questioned the results for multiple patients tested for creatinine jaffé gen.2 (crej2) on a cobas 6000 c (501) module.The customer provided discrepant results for 2 patient samples.Patient 1 initial result was 1.29 mg/dl.The repeat result was 0.80 mg/dl.Patient 2 initial result was 1.51 mg/dl.The repeat result was 0.95 mg/dl.The initial results were reported outside of the laboratory.The repeat results were believed to be correct.The c501 module serial number was (b)(4).

• Brand Name: CREJ2
• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15848662
• Report Number: 1823260-2022-03748
• Device Sequence Number: 5202096
• Product Code: CGX
• UDI-Device Identifier: 04015630922284
• UDI-Public: 04015630922284
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K941837
• 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
• Report Date (Section B): 11/22/2022

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: 03/31/2024
• Device Model Number: CREAJ
• Device Catalogue Number: 04810716190
• Device Lot Number: 647264
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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