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

Catalog Number 03183696122

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2020

Event Type  malfunction  

Manufacturer Narrative

The reporter stated she was concerned with the iron reagent stability on the analyzer.The reagent pack that was in use had 54 tests left and the reporter believes controls will start to drift when packs have been left on board for a long time.Controls still recover within specifications.

Event Description

The initial reporter stated they received discrepant results for four patient samples tested with iron2 iron gen.2 on a cobas 8000 c 502 module.The initial values were reported outside of the laboratory.The reporter replaced the reagent cassette as controls had failed, then repeated the samples on (b)(6) 2020.The repeat values were believed to be correct and corrected reports were issued.The first sample initially resulted with an iron value of 19 ug/dl, which repeated as 7 ug/dl.The second sample initially resulted with an iron value of 28 ug/dl, which repeated as 17 ug/dl.The third sample initially resulted with an iron value of 30 ug/dl, which repeated as 15 ug/dl.The fourth sample initially resulted with an iron value of 41 ug/dl, which repeated as 26 ug/dl.The serial number of the c502 analyzer is (b)(4).

Manufacturer Narrative

The manufacturer's investigations found that the screw caps on the non-iron reagents cause abrasion on the steel needle transporting small amounts of iron into the iron reagent.These iron traces accumulate over time causing a drift in recovery especially in high throughput laboratories.The issue is only visible in mixed operation of the analyzer (iron pipetted alternating with other reagents) and on analyzers having a high iron throughput per day.The drift can be detected by control measurement and calibration brings control recovery back to previous levels.

Manufacturer Narrative

Medwatch fields h7.And h9.Have been updated.

• 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: 9917339
• MDR Text Key: 221998922
• Report Number: 1823260-2020-00927
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 03183696122
• Device Lot Number: 42908701
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 87854
• Patient Sequence Number: 1