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)

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

Event Date 10/25/2023

Event Type  malfunction  

Manufacturer Narrative

The e602 module serial number was (b)(6).

Event Description

The initial reporter complained of a discrepant high result for 1 patient sample tested for crep2 on a cobas 8000 c 702 module.The initial result was 1.14 mg/dl.The repeat result was 0.86 mg/dl.The low result was believed to be correct.The questionable result was not reported outside of the laboratory.

Manufacturer Narrative

Section d, device identification was updated.Relevant fields of sections d and g were updated.The crep2 reagent lot number and expiration date were not provided.The field service engineer (fse) replaced the gear pump, cleaned the probes, and cleaned and adjusted the rinse station flows.Calibration and qc were acceptable.The maintenance actions resolved the issue.

• 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: 18153830
• MDR Text Key: 328324640
• Report Number: 1823260-2023-03637
• Device Sequence Number: 1
• Product Code: JFY
• UDI-Device Identifier: 04015630924998
• UDI-Public: 04015630924998
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: K100853
• 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: 11/28/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• 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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1