MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INTEGRA CREATININE PLUS VER.2 ASSAY; ENZYMATIC METHOD, CREATININE

Catalog Number	03263991190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable crep2 creatinine plus ver.2 results for 2 patient samples on a cobas integra 400 plus.For sample 1, the initial crep2 result was 190.6 umol/l.The repeat result was 67.5 umol/l.For sample 2, the initial crep2 result was 101.7 umol/l.The first repeat result was 185.7 umol/l and the second repeat result was 101.7 umol/l.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The calibration and qc recovery data provided was acceptable.The alarm trace showed multiple no fluid alarms.The field service engineer (fse) found that the distributor fluid transfer head had crystallization and was leaking and replaced it.The investigation is ongoing.
Additional Manufacturer Narrative
It was found that the customer was operating the analyzer with the front cover open which should be closed as the loaded reagents must be kept at 8 degrees centigrade.The investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
• 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: 17957104
• Report Number: 1823260-2023-03336
• Device Sequence Number: 5282723
• Product Code: JFY
• UDI-Device Identifier: 04015630919215
• UDI-Public: 04015630919215
• Combination Product (Y/N): Y
• Initial Reporter Country: SF
• 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): 12/01/2023

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: 10/31/2023
• Device Catalogue Number: 03263991190
• Device Lot Number: 706163
• 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: 09/19/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 12/01/2023
• 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 Age: 34 YR
• Patient Sex: Male