MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREP2; ENZYMATIC METHOD, CREATININE

Model Number	CREP G2
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: na.
Event or Problem Description
The initial reporter stated they received discrepant results for an unspecified number of patient samples tested with the crep2 (creatinine plus ver.2) assay on a cobas 8000 c702 module, serial number (b)(6).The following examples of discrepant crep2 results were provided by the customer: patient sample 1: the sample initially resulted in a crep2 value of 259 umol/l and repeated as 179 umol/l on a second instrument line.Patient sample 2: the sample initially resulted in a crep2 value of 60 umol/l.The sample was repeated three times on a second instrument line resulting in values of 42 umol/l, 45 umol/l, and 111 umol/l.It was asked but it is unclear which results are correct.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
Based on the information provided, the investigation did not identify a product problem.The cause of the event could not be determined.
Additional Manufacturer Narrative
"abnormal sample aspiration" and "sample short" alarms occurred frequently on the alarm trace data.The field service engineer (fse) checked multiple parts of the instrument, decontaminated all lines, and performed air purges, mechanical checks, and photometer checks.The fse performed cell blank calibration after replacing the incubator rinse water.Calibration and qc were performed.The investigation is ongoing.

• Brand Name: CREP2
• Common Device Name: ENZYMATIC METHOD, 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: 16888649
• Report Number: 1823260-2023-01543
• Device Sequence Number: 14975269
• Product Code: JFY
• UDI-Device Identifier: 04015630924998
• UDI-Public: 04015630924998
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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,Followup
• Report Date (Section B): 07/17/2023

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: 11/30/2023
• Device Model Number: CREP G2
• Device Catalogue Number: 05168589190
• Device Lot Number: 70264101
• 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: 04/12/2023
• Supplement Date Received by Manufacturer: 05/09/2023; 06/25/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 05/30/2023; 07/17/2023
• 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