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 06/14/2023

Event Type  malfunction  

Manufacturer Narrative

The analyzer serial number is 421310.The investigation is ongoing.

Event Description

There was an allegation of questionable iron2 iron gen.2 results for 1 patient sample on a cobas integra 400 plus module.The initial iron result was 3.2 mcg/dl.The sample was repeated on another integra 400 analyzer and the result was 29.2 mcg/dl.The repeat result was deemed correct.No questionable results were reported outside of the laboratory.

Manufacturer Narrative

Calibration was last performed on (b)(6) 2023.The qc recovery data provided was acceptable.Based on the available data, a general reagent issue could be excluded.The alarm trace showed clot detection alarms on the day of the event.The root cause of the event was found to be consistent with pre-analytical sample handling issues.The investigation did not identify a product problem.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17310423
• MDR Text Key: 319134294
• Report Number: 1823260-2023-02239
• Device Sequence Number: 1
• Product Code: JIY
• UDI-Device Identifier: 04015630918904
• UDI-Public: 04015630918904
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 08/29/2023

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: 11/30/2023
• Device Catalogue Number: 03183696122
• Device Lot Number: 693376
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 08/04/2023
• Supplement Dates FDA Received: 08/29/2023
• 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
• Patient Age: 3 YR
• Patient Sex: Female