MAUDE Adverse Event Report: ROCHE DIAGNOSTICS FERR4; FERRITIN

Catalog Number	08057648190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the cobas pro c 503 analytical unit was (b)(6).The field service engineer replaced the reaction cells and ran precision studies.Controls were tested and all results were within the customer's specified ranges except for one level of control tested with a new lot of ferritin reagent.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with ferr4 (ferritin) on a cobas pro c 503 analytical unit.The customer noted that controls were running high with a new lot of ferritin reagent.The sample initially resulted in a ferritin value of 7 ng/ml.Controls tested after the initial sample run were outside of range, so the sample was repeated.The sample repeated with a ferritin value of 11 ng/ml.This repeat value was deemed correct and a corrected report was issued.
Additional Manufacturer Narrative
There were no alarms on the last calibrations performed on 13-jun-2023 and 14-jun-2023.Quality control recovery was within range.There was no indication of a reagent performance issue.Upon review of the alarm trace, multiple abnormal aspiration alarms were observed.This is an indication of possible poor sample quality.The investigation determined the service actions resolved the issue.

• Brand Name: FERR4
• Common Device Name: FERRITIN
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17309096
• Report Number: 1823260-2023-02226
• Device Sequence Number: 6506311
• Product Code: DBF
• UDI-Device Identifier: 07613336121238
• UDI-Public: 07613336121238
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 08/22/2023

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: 06/30/2024
• Device Catalogue Number: 08057648190
• Device Lot Number: 64873101
• 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: 06/17/2023
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/22/2023
• 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 Age: 49 YR
• Patient Sex: Female