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

Model Number	CREP G2
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable crep2 creatinine plus ver.2 result for a patient sample tested on a cobas 6000 c 501 module with serial number (b)(4).The initial result was reported outside of the laboratory.On (b)(6) 2022, the initial result was 58.3 mg/dl.The first repeat result was 57.8 mg/dl with a data flag.The first repeat result was from an automatic rerun because of a middleware rule.The patient was sent to the emergency room (er) because they thought he had renal insufficiency.At the er, his creatinine result was reported to be at a low level.On (b)(6) 2022, the reporter reran the initial sample.The second repeat result was 48.6 mg/dl.The reporter also reran the same sample collected in a tube with a gel separator.The third repeat result was 8.6 mg/dl.
Additional Manufacturer Narrative
A general reagent or hardware problem can be excluded because the provided calibration and qc data were within specifications.The reaction kinetics looked inconspicuous.The investigation did not identify a product problem.

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14268526
• Report Number: 1823260-2022-01237
• Device Sequence Number: 11850799
• Product Code: JFY
• UDI-Device Identifier: 04015630919215
• UDI-Public: 04015630919215
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 11/09/2022

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: 11/30/2022
• Device Model Number: CREP G2
• Device Catalogue Number: 03263991190
• Device Lot Number: 620666
• 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: 04/05/2022
• Supplement Date Received by Manufacturer: 10/16/2022
• Initial Report FDA Received Date: 05/03/2022
• Supplement Report FDA Received Date: 11/09/2022
• 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