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	09/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable creatinine plus ver.2 result for 1 patient sample on a cobas 8000 c701 module.The initial result was reported outside of the laboratory.The physician questioned the result.A new sample was collected from the patient.The reporter is looking for a medical explanation for such a decrease in the results.It was alleged that the difference in results between the two samples was not possible due to the patient¿s condition.On (b)(6) 2022 , the initial result of the initial sample was 134 umol/l.On (b)(6) 2022 , the result of the new sample was 77 umol/l.The c701 module serial number was (b)(4).
Additional Manufacturer Narrative
The calibration data provided from 03-sep-2022 to 13-sep-2022 was within specifications.The alarm trace showed multiple sample short alarms.The preanalytical checklist showed that the centrifugation condition was 2200 g for 11 minutes.According to the manufacturer's recommendation, the centrifugation conditions should be 1300-2000 g for 10 minutes.The investigation determined the event was due to a preanalytic issue at the customer site.Preanalytics are within the customer's responsibility.There was no indication of a device malfunction.

• 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: 15680166
• Report Number: 1823260-2022-03368
• Device Sequence Number: 17735439
• Product Code: JFY
• UDI-Device Identifier: 04015630924998
• UDI-Public: 04015630924998
• 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): N
• 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): 11/28/2022

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: 05/31/2023
• Device Model Number: CREP G2
• Device Catalogue Number: 05168589190
• Device Lot Number: 657574
• 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: 09/30/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 11/28/2022
• 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 Age: 70 YR
• Patient Sex: Female