MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREATININE JAFFE GEN.2; CREATININE, ALKALINE PICRATE COLORIMETRY

Catalog Number	08057532190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's c 303 analyzer is 2115-03.The serial numbers of all other analyzers was requested, but not provided.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for three samples collected from the same patient and tested with creatinine jaffe gen.2 on a cobas pure c 303 analytical unit and cobas integra 400 plus analyzers.The second and third samples were also tested on a c303 analyzer, a cobas c 311 analyzer, and two additional integra 400 plus analyzers at other sites.The first sample resulted in a creatinine value of 102 umol/l when tested on the customer's c 303 analyzer.The sample was repeated on the customer's integra 400 plus analyzer, resulting in a value of 39 umol/l.The second sample resulted in the following creatinine values: on the customer's c 303 analyzer = 109 umol/l and 108 umol/l on the customer's integra 400 plus analyzer = 42 umol/l and 45 umol/l on a second c303 system at a second site = 105 umol/l on a c311 analyzer at a second site = 84 umol/l and 90 umol/l with a data flag on a second integra 400 plus analyzer at a third site = 51 umol/l on a third integra 400 plus analyzer at a third site = 46 umol/l the third sample resulted in the following creatinine values: on the customer's c 303 analyzer = 120 umol/l on the customer's integra 400 plus analyzer = 52 umol/l at the customer site using a rapid test strip method (stat sensor express) = 110 umol/l on a second c303 system at a second site = 108 umol/l on a c311 analyzer at a second site = 93 umol/l on a second integra 400 plus analyzer at a third site = 48 umol/l on a third integra 400 plus analyzer at a third site = 47 umol/l.
Additional Manufacturer Narrative
The patient sample's icterus index from the cobas integra 400 plus was 314 (significantly above the limit).The investigation determined the event was consistent with an icteric patient sample.Product labeling states: "limitations ¿ interference serum/plasma icterus (crej2) - no significant interference up to an i index of 5 for conjugated bilirubin and 10 for unconjugated bilirubin (approximate conjugated bilirubin concentration: 86 mol/l or 5 mg/dl; approximate unconjugated bilirubin concentration: 171 mol/l or 10 mg/dl." based on the provided information, the investigation did not identify a product problem.

• Brand Name: CREATININE JAFFE GEN.2
• Common Device Name: CREATININE, ALKALINE PICRATE COLORIMETRY
• 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 46250-0457
• MDR Report Key: 20831414
• Report Number: 1823260-2024-03499
• Device Sequence Number: 12921219
• Product Code: CGX
• UDI-Device Identifier: 07613336121177
• UDI-Public: 07613336121177
• Combination Product (Y/N): N
• Initial Reporter Country: AM
• PMA/510(K) Number: K951595
• 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): 02/25/2025

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: 08/31/2025
• Device Catalogue Number: 08057532190
• Device Lot Number: 759219
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 02/25/2025
• 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 Age: 6 MO
• Patient Sex: Unknown
• Patient Weight: 7 KG