MAUDE Adverse Event Report: ROCHE DIAGNOSTICS IRON2; 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 08/23/2023

Event Type  malfunction  

Manufacturer Narrative

One of the integra 400 plus modules' serial number is (b)(6).The other module's serial number was not provided.The investigation is ongoing.

Event Description

There was an allegation of questionable iron2 iron gen.2 results for 2 patient samples on two cobas integra 400 plus modules.For sample 1, the initial iron result was 3.65 ug/dl.The sample was repeated on another integra 400 plus module and the result was 14.48 ug/dl.For sample 2, the initial iron result was 13.46 ug/dl.The sample was repeated on another integra 400 plus module and the result was 25.30 ug/dl.Clarification on which analyzer produced which results was not provided.

Manufacturer Narrative

The calibration and qc recovery data provided was acceptable.The alarm trace showed multiple no fluid detected alarms.The field service engineer (fse) found a problem with the analyzer lamp and replaced it.The root cause of the event was found to be consistent with customer maintenance issues.

• Brand Name: IRON2
• 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: 17775455
• MDR Text Key: 323754292
• Report Number: 1823260-2023-03023
• Device Sequence Number: 1
• Product Code: JIY
• Combination Product (y/n): Y
• Reporter Country Code: RO
• 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,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 03183696122
• Device Lot Number: 71147001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 11/16/2023
• Supplement Dates FDA Received: 12/07/2023
• 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