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

Catalog Number	03183696122
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.The event was consistent with a sample handling or maintenance issue.As the issue appeared to be resolved by using a new reagent cassette, a general issue was unlikely.
Event or Problem Description
There was an allegation of a questionable low iron gen.2 result from cobas integra 400 plus analyzer serial number (b)(4).The initial result was 1.6 mol/l.The same sample was tested in another laboratory with an abbott instrument and the result was 6.1 mol/l.After the customer replaced the reagent cassette, the same sample was repeated and the result was equal to that obtained on the abbott instrument.No specific data was provided.The questionable result was not reported outside of the laboratory.

• Brand Name: IRON GEN.2
• Common Device Name: PHOTOMETRIC METHOD, IRON (NON-HEME)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12266276
• Report Number: 1823260-2021-02255
• Device Sequence Number: 5128109
• Product Code: JIY
• UDI-Device Identifier: 04015630918904
• UDI-Public: 04015630918904
• Combination Product (Y/N): N
• Initial Reporter Country: BK
• PMA/510(K) Number: K892838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 03183696122
• Device Lot Number: 538624
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1