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

Catalog Number	05168589190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c702 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received a questionable result for one patient sample tested with crep2 on a cobas 8000 c702 module.The patient sample initially resulted in a negative value for creatinine on the c702 analyzer.An interference was suspected and a serial dilution of the sample was performed using water and a creatinine result of 30 umol/l was obtained on the c702 analyzer.The patient sample was sent to another laboratory where an unknown creatinine jaffe method was used, resulting in a creatinine value of 56 umol/l.The customer performed a polyethylene glycol (peg) precipitation of the sample and repeated on the c702 analyzer and the creatinine result was 50 umol/l.
Additional Manufacturer Narrative
The last calibration performed on (b)(6) 2023 was ok.Quality controls recovered within range.A general reagent issue can be ruled out since calibration and qc data are acceptable.The patient had a high igm result of 17.55 g/l.Per product labeling, "in very rare cases, gammopathy, in particular type igm (waldenström¿s macroglobulinemia), may cause unreliable result." the investigation could 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17577898
• Report Number: 1823260-2023-02707
• Device Sequence Number: 8267756
• Product Code: JFY
• UDI-Device Identifier: 04015630924998
• UDI-Public: 04015630924998
• Combination Product (Y/N): Y
• Initial Reporter Country: SN
• 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): 09/05/2023

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: 11/30/2023
• Device Catalogue Number: 05168589190
• Device Lot Number: 71018001
• 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: 07/20/2023
• Supplement Date Received by Manufacturer: 09/04/2023
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 09/05/2023
• 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
• Patient Sex: Female