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

Catalog Number 03263991190

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 09/18/2023

Event Type  malfunction  

Event 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.

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.

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
• 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: 17957104
• MDR Text Key: 325938090
• Report Number: 1823260-2023-03336
• Device Sequence Number: 1
• Product Code: JFY
• UDI-Device Identifier: 04015630919215
• UDI-Public: 04015630919215
• Combination Product (y/n): Y
• Reporter Country Code: SF
• 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: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/13/2023
• 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: 34 YR
• Patient Sex: Male