MAUDE Adverse Event Report: ROCHE DIAGNOSTICS IRON2; PHOTOMETRIC METHOD, IRON (NON-HEME)

Catalog Number	03183696122
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable iron gen.2 results on a cobas 6000 c501 (ul) v.The reporter used previous patient samples to do a lot-to-lot correlation.For patient #1, the previous iron result was 35 ug/dl.The repeat result on the new lot was 57 ug/dl.For patient #2, the previous iron result was 43 ug/dl.The repeat result on the new lot was 21 ug/dl.The previous results were reported outside of the laboratory.It is not known which result is deemed correct.The old lot was 59326101 and the expiration date is 30-nov-2022.The new lot was 60819101 and the expiration date is 31-jan-2023.The instrument serial number is (b)(4).
Additional Manufacturer Narrative
The reporter received calibration errors and failed lot to lot comparisons.It was determined that air bubbles in the reagent pack were affecting results.Cal and qc passed after manually removing bubbles from the reagent pack.The investigation is ongoing.
Additional Manufacturer Narrative
It was determined that the discrepant results were due to customer handling of reagents which caused the formation of foam in the reagents.Product labeling states: "foam on top or bubbles in reagents can cause pipetting volume shortage and lead to incorrect results.Avoid the formation of foam in all reagent types.Do not shake reagents." and "do not shake the cobas c pack to avoid foaming." there were multiple calibration failures and controls were outside of the high range on the day of the event.Successful calibration and controls were then measured later that day.Abnormal probe aspiration errors were observed on the alarm trace.These are indicators of possible poor sample quality the issue was resolved by removing the bubbles and repeating calibration, qc, and patient correlations successfully.

• Brand Name: IRON2
• Common Device Name: 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: 14885881
• Report Number: 1823260-2022-01948
• Device Sequence Number: 5040130
• Product Code: JIY
• UDI-Device Identifier: 04015630918904
• UDI-Public: 04015630918904
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

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: 01/31/2023
• Device Catalogue Number: 03183696122
• Device Lot Number: 60819101, 59326101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2022
• Supplement Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown