MAUDE Adverse Event Report: ROCHE DIAGNOSTICS IRON GEN.2; PHOTOMETRIC METHOD, IRON (NON-HEME)

Catalog Number 03183696122

Device Problem Non Reproducible Results (4029)

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

Event Date 03/27/2024

Event Type  malfunction  

Manufacturer Narrative

The c501 module serial number was (b)(6).

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for iron gen.2 (iron2) on a cobas 6000 c501 module.The initial result was 15.30 ug/dl.The sample was repeated 3 times with results of 25.90 ug/dl, 16.50 ug/dl, and 16.10 ug/dl.

Manufacturer Narrative

Calibration and qc were acceptable, therefore, a general reagent issue can be excluded.Based on the information provided, the investigation determined the event was consistent with a preanalytical handling issue.The investigation did not identify a product problem.

• Brand Name: IRON GEN.2
• Type of Device: PHOTOMETRIC METHOD, IRON (NON-HEME)
• 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: 19106477
• MDR Text Key: 340349303
• Report Number: 1823260-2024-01155
• Device Sequence Number: 1
• Product Code: JIY
• UDI-Device Identifier: 04015630918904
• UDI-Public: 04015630918904
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K951595
• 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: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03183696122
• Device Lot Number: 77213201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• 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