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

Catalog Number 05168589190

Device Problems High Test Results (2457); Non Reproducible Results (4029)

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

Event Date 10/24/2023

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for seven patient samples tested with crep2 (creatinine) on a cobas 8000 c 701 module.Refer to the attachment for all patient data.

Manufacturer Narrative

The serial number of the c 701 module is (b)(6).The field service engineer decontaminated the aspiration lines, cleaned the washing head, performed probe adjustments, and checked the gear pump settings.A vacuum pump diaphragm was replaced.The investigation is ongoing.

Manufacturer Narrative

The initial reporter stated that they had a total of 83 patient samples with questionable results.One of the involved patients had a new sample collected and this sample had a normal creatinine result.It was asked, but it is not known which specific sample corresponds to this patient.Another of the involved patients received a computed tomography scan and x-rays due to a questionable creatinine result.It was asked, but it is not known which specific sample corresponds to this patient.

Manufacturer Narrative

A reagent issue can be excluded as calibration and controls are acceptable.The investigation determined the service actions resolved the issue.The issue is consistent with insufficient maintenance.

• 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: 18139196
• MDR Text Key: 328149999
• Report Number: 1823260-2023-03613
• Device Sequence Number: 1
• Product Code: JFY
• UDI-Device Identifier: 04015630924998
• UDI-Public: 04015630924998
• Combination Product (y/n): Y
• Reporter Country Code: CO
• 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,Followup
• Report Date: 01/22/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 05168589190
• Device Lot Number: 71018001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2024
• 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
• Treatment: REFER TO ATTACHMENT FOR PATIENT MEDICATIONS