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

Catalog Number 05168589190

Device Problem Low Test Results (2458)

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

Event Date 11/22/2023

Event Type  malfunction  

Event Description

The initial reporter received a questionable crep2 (creatinine) result from one patient sample tested on the cobas 8000 c702 module.On (b)(6) 2023: the initial result from the module was 0.13 mg/dl.The first repeat result from the other module was 1.22 mg/dl.The second repeat result from the other module was 1.20 mg/dl.On (b)(6) 2023: the third repeat result from the module was 1.19 mg/dl.

Manufacturer Narrative

The serial number of the customer's cobas 8000 c702 module is (b)(6).The investigation is ongoing.

Manufacturer Narrative

Medwatch fields d.Device identification and g4 pma / 510k (premarket numbers) were updated.The field service engineer (fse) replaced the tube rinse station and the gear pump.The module was verified to be working within specification again.The investigation reviewed the qc data; the results were within specifications.The investigation excluded a reagent issue.The investigation determined the event was caused by a service maintenance-related issue.After service, no further issues were reported by the customer.The investigation determined the service 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: 18325604
• MDR Text Key: 330490891
• Report Number: 1823260-2023-03978
• 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: 02/07/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• 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: 75173401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• 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