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

Catalog Number 05168589190

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the c702 analyzer is (b)(6).The investigation is ongoing.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 321558620
• Report Number: 1823260-2023-02707
• Device Sequence Number: 1
• Product Code: JFY
• UDI-Device Identifier: 04015630924998
• UDI-Public: 04015630924998
• Combination Product (y/n): Y
• Reporter Country Code: SN
• PMA/PMN Number: K024098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 91 YR
• Patient Sex: Female