MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREP2; CREATININE TEST SYSTEM

Catalog Number 08057524190

Device Problem High Test Results (2457)

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

Event Date 12/10/2023

Event Type  malfunction  

Manufacturer Narrative

The cobas pure c 303 analytical unit serial number was (b)(6).The investigation is ongoing.

Event Description

There was an allegation of questionable creatinine (crep2) results from the cobas pure c 303 analytical unit.The samples were repeated on (b)(6) 2023.Sample (b)(6) initial result was 42.6 umol/l and the repeat result was 36.3 umol/l.Sample (b)(6) initial result was 29.4 umol/l and the repeat result was 21 umol/l.Sample (b)(6) initial result was 25.3 umol/l and the repeat result was 18.1 umol/l.Sample (b)(6) initial result was 21.3 umol/l and the repeat result was 11.5 umol/l.Sample (b)(6) initial result was 29.4 umol/l and the repeat result was 18.4 umol/l.Sample (b)(6) initial result was 89.2 umol/l and the repeat result was 61.9 umol/l.Sample (b)(6) initial result was 47.5 umol/l and the repeat result was 25.6 umol/l.

Manufacturer Narrative

Medwatch fields d1-d4, g1, and g4 were updated.The field service engineer checked the cell detergent volume.He replaced the reagent probes and adjusted the height.After the service visit, no further issues were reported, a regent or sample carryover issue could be excluded.The investigation determined the service actions resolved the issue.

• Brand Name: CREP2
• Type of Device: CREATININE TEST SYSTEM
• 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: 18401531
• MDR Text Key: 331690467
• Report Number: 1823260-2023-04180
• Device Sequence Number: 1
• Product Code: JFY
• UDI-Device Identifier: 07613336121160
• UDI-Public: 07613336121160
• Combination Product (y/n): Y
• Reporter Country Code: SA
• PMA/PMN Number: K812095
• 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
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08057524190
• Device Lot Number: 729539
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2023
• 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