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 02/18/2020

Event Type  malfunction  

Manufacturer Narrative

The field service engineer could not determine a cause.Rinse mechanism levels and pump pressures were checked, with no abnormalities noted.Precision studies were performed and all values recovered within guidelines.The customer ran calibration and controls.Controls recovered within range.No alarms were noted on the last calibration performed on (b)(6) 2020.Quality control data was evaluated and controls were within range, showing no indication of a reagent or instrument performance issue.The investigation could not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter stated they received discrepant results for two patient samples tested with iron2 iron gen.2 on a cobas 8000 c 502 module.On (b)(6) 2020, controls passed for the iron reagent pack that was in use.On (b)(6) 2020, controls failed on the reagent pack and it had to eventually be replaced.It was noted that the complained reagent pack was near the end of its test volume.The customer repeated patient samples tested on (b)(6) 2020 and two samples had discrepant results.The initial values from these samples were reported outside of the laboratory.The repeat values were believed to be correct and corrected reports were issued.The first sample initially resulted with an iron value of 33 ug/dl and repeated as 19 ug/dl.The second sample, from a male patient, initially resulted with an iron value of 30 ug/dl and this repeated as 13 ug/dl.The c 502 analyzer serial number is (b)(4).

• 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
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 9828440
• MDR Text Key: 205963072
• Report Number: 1823260-2020-00721
• Device Sequence Number: 1
• Product Code: JIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K892838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/13/2020

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: 10/31/2020
• Device Catalogue Number: 03183696122
• Device Lot Number: 44323201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 03/13/2020
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1