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

Catalog Number	05168589190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the cobas 8000 c702 module is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with crep2 (creatinine) on a cobas 8000 c702 module.The sample initially resulted in a creatinine value of 72 umol/l.The sample was then repeated using the creatinine jaffe method and the creatinine value was 169 umol/l.The sample was then diluted 1:3 and repeated using the original crep2 method and the creatinine value was 105 umol/l accompanied by a data flag.The 169 umol/l value was reported to the patient because it agreed with the patient's clinical picture.
Additional Manufacturer Narrative
A sample from the patient was provided for investigation.Initial investigations of the patient sample were able to duplicate the results obtained by the customer.The patient was diagnosed with hydrocephalus, sepsis, insulin-dependent diabetes mellitus, and pneumonia.The complained patient sample had a high glucose concentration of 34.07 mmol/l.The patient's total protein level was not elevated.Medwatch field d10 (concomitant medications) has been updated.
Additional Manufacturer Narrative
Further investigation testing was performed to rule out a potential interference.All tested parameters were within the normal range.A specific root cause could not be determined based on the provided information.No general product problem was found.

• 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)
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250-0457
• MDR Report Key: 17439759
• Report Number: 1823260-2023-02498
• Device Sequence Number: 2905514
• Product Code: JFY
• UDI-Device Identifier: 04015630924998
• UDI-Public: 04015630924998
• Combination Product (Y/N): Y
• Initial Reporter Country: HR
• 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): 10/05/2023

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: 08/31/2023
• Device Catalogue Number: 05168589190
• Device Lot Number: 67400001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/18/2023
• Supplement Date Received by Manufacturer: 09/05/2023; 10/04/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 09/06/2023; 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: CONCOR COR (1 X 1); EUTHYROX (1 X 1); FURSEMID (1 X 1); NOVORAPID (2X); ROSWERA (1 X 1)
• Patient Sex: Unknown