MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREJ2 CREATININE JAFFÉ GEN.2 - COMPENSATED METHOD FOR SERUM AND PLASMA; ALKALINE PICRATE, COLORIMETRY, CREATININE

Model Number	CREAJ
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable crej2 creatinine jaffé gen.2 results for 1 patient on a cobas 6000 c501 module, serial number (b)(4).The following results were obtained from different samples: on (b)(6) 2021 the result was 0.72 mg/dl.On (b)(6) 2021 the result was 0.60 mg/dl.On (b)(6) 2021 the result was 0.50 mg/dl.On (b)(6) 2021 the result was 0.47 mg/dl.On (b)(6) 2022 the result was 0.62 mg/dl.On (b)(6) 2022 the result was 4.47 mg/dl.On (b)(6) 2022 the result was 4.51 mg/dl.On (b)(6) 2022 the result was 7.22 mg/dl.On (b)(6) 2022 the result was 7.03 mg/dl.On (b)(6) 2022 the result was 5.58 mg/dl.On (b)(6) 2022 the result was 6.11 mg/dl and 6.31 mg/dl.The results were reported outside of the laboratory.The patient's nephrologist does not believe the increasing creatinine results are correct because the patient's urea result is below 10 mg/dl.The doctor expects the patient's creatinine result to be <1.2 mg/dl.The reagent lot number and expiration date were requested, but not provided.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.The malnutrition of the patient (severely starving) was determined to be the most probable cause of the issue as the high creatinine results and normal urea levels would be due to a reduction in muscle mass within a short timeframe.The high creatinine values were confirmed with the enzymatic creatinine method, so interference was not suspected.Since the values are consistently high, a gammopathic interference was not likely.

• Brand Name: CREJ2 CREATININE JAFFÉ GEN.2 - COMPENSATED METHOD FOR SERUM AND PLASMA
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13538872
• Report Number: 1823260-2022-00389
• Device Sequence Number: 4162177
• Product Code: CGX
• UDI-Device Identifier: 04015630922284
• UDI-Public: 04015630922284
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2022

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 Model Number: CREAJ
• Device Catalogue Number: 04810716190
• Device Lot Number: ASKU
• 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: 01/24/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 07/08/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VANCOMYCIN
• Patient Sex: Unknown