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

Model Number	CREP G2
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.There were no follow up/corrective actions.The reported event involved an automated analytical device which is serviced in the field and not routinely returned for investigation.This device is not labeled for single use and is not reprocessed or reused.
Event or Problem Description
This report summarizes 1 malfunction event.Erroneous high results were generated by the cobas 6000 c (501) module.The event involved a total of 1 patient with the following: one erroneous result for crej2 creatinine jaffé gen.2.
Additional Manufacturer Narrative
Correction for medwatch field b5.The following statement was reported on the previous medwatch: "the event involved a total of 1 patient with the following: one erroneous result for crej2 creatinine jaffé gen.2." this statement is updated to: "the event involved a total of 1 patient with the following: two erroneous results for crej2 creatinine jaffé gen.2.".

• Brand Name: CREATININE PLUS VER.2
• Common Device Name: ENZYMATIC METHOD, CREATININE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8544214
• Report Number: 1823260-2019-90100
• Device Sequence Number: 373979
• Product Code: JFY
• UDI-Device Identifier: 04015630919215
• UDI-Public: 04015630919215
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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?: No
• Operator of Device: No Information
• Device Model Number: CREP G2
• Device Catalogue Number: 3263991190
• Device Lot Number: ASKU
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 04/16/2020
• Patient Sequence Number: 1