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

Catalog Number 03183696122

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2020

Event Type  malfunction  

Manufacturer Narrative

The field service engineer found there was an issue with the iron reagent cassette.He checked the instrument for issues and found none.He ran precision testing which passed.The investigation is ongoing.

Event Description

The initial reporter received questionable iron2 iron gen.2 results for four patient samples from cobas 8000 cobas c 502 module serial number (b)(4).Sample 1 initial result was 31 ug/dl and the repeat result was 18 ug/dl.Sample 2 initial result was 45 ug/dl and the repeat result was 28 ug/dl.Sample 3 initial result was 35 ug/dl and the repeat result was 19 ug/dl.Sample 4 initial result was 33 ug/dl and the repeat result was 17 ug/dl.The questionable results were corrected.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined. .

• 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
• MDR Report Key: 10764309
• MDR Text Key: 215111620
• Report Number: 1823260-2020-02717
• Device Sequence Number: 1
• Product Code: JIY
• Combination Product (y/n): N
• PMA/PMN Number: K892838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 03183696122
• Device Lot Number: 463917
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: 10/09/2020
• Supplement Dates FDA Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1