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

Catalog Number 05168589190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Output Problem (3005)

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

Event Date 09/11/2023

Event Type  malfunction  

Event Description

There was an allegation of questionable crep2 creatinine plus ver.2 results for 2 patient samples on a cobas 8000 c702 module.For sample 1, the initial creatinine result was 5.1 mg/dl.The repeat result was 1.3 mg/dl.For sample 2, the initial creatinine result was 4.2 mg/dl.The repeat result was 0.8 mg/dl.

Manufacturer Narrative

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

Manufacturer Narrative

Section d product information has been updated, as well as g1 manufacturing site and g4.The customer stated verbally that their qc recovery data was acceptable.The field service engineer (fse) replaced reagent probes, decontaminated the flow path, and performed a precision test and mechanical checks successfully.The customer performed qc successfully.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.

• Brand Name: CREP2
• Type of Device: ENZYMATIC METHOD, CREATININE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 17939751
• MDR Text Key: 325736524
• Report Number: 1823260-2023-03305
• Device Sequence Number: 1
• Product Code: JFY
• UDI-Device Identifier: 04015630924998
• UDI-Public: 04015630924998
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K100853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05168589190
• Device Lot Number: 710180
• 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