MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS IGFBP-3; RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE

Catalog Number	07574690190
Medical Device Problem Codes	Product Quality Problem (1506); Incorrect, Inadequate or Imprecise Result or Readings (1535); Improper or Incorrect Procedure or Method (2017); High Test Results (2457)
Health Effect - Clinical Codes	Hormonal Imbalance (4495); Insufficient Information (4580)
Date of Event	05/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
We received an allegation that the elecsys igfbp-3 assay and elecsys igf-1 assay results may have contributed to a negative impact on patients' growth and the patients were reportedly not progressing as expected.This mdr is for the elecsys igfbp-3 assay.Refer to mdr with patient identifier: (b)(6) for the elecsys igf-1 assay.The reporter stated that pediatric endocrinologists have raised a concern about the igf-1 and igfbp3 results.They reportedly noticed that the values have been higher than the previous method (the immulite) and have been reportedly treating their patients based on the higher results.The reporter stated that during validation prior to changing to the roche method, the e411 was reportedly running higher than the immulite.Most samples reportedly stayed within or outside of the reference range.The reporter stated that they thought that the previous system was too low, not that the roche was too high.The reporter stated they had changed the reference range to reflect the roche reference range.This reportedly had increased slightly from the previous methodology.The reporter went on to state that after the physicians treated their patients based on roche's results, they saw a negative impact on their patients' growth and the patients were reportedly not progressing as expected.Additional information was requested, but could not be obtained despite multiple follow-up attempts.This information includes: clarification regarding the allegation: "a negative impact to their growth" and "patients were not progressing in growth as expected." clarification whether the therapeutic dosage changed for the affected children, or if the therapeutic dosage was scheduled from the beginning at an insufficient level? this mdr is being submitted with an abundance of caution.
Additional Manufacturer Narrative
On follow-up, the reporter stated that it appears the assay is working as expected.The reporter stated that their physicians' concern was with the interpretation and comparison of the roche results to a previous method.The investigation is ongoing.
Additional Manufacturer Narrative
The serial number of the cobas e411 disk with serial number (b)(6).
Additional Manufacturer Narrative
The customer confirmed their rejection of the allegation of unanticipated serious deterioration in health and that the statement that the patients were not progressing in growth as expected is no longer part of the allegation.At no point has anyone connected with the case provided any evidence of no progression in the growth of the pediatric patients as expected, despite having been asked multiple times on different days at different times.The calibration data, qc recovery, preanalytical data, alarm trace, and service information were requested but were not provided.The cause of the event could not be determined. .
Additional Manufacturer Narrative
The field application specialist (fas) collected calibration performance and other data for review.The last calibration performed on (b)(6) 2023 had calibrator signals that were slightly higher than the expected calibrator signals but this does not appear to affect the performance of the calibration.There were no alarms noted.The qc recovery on the date of the event was within the customer¿s established ranges.There is no indication of a performance issue with the reagent or instrument.Based on the data provided, the cause of the event could not be determined.A general instrument or reagent problem could not be identified.

• Brand Name: ELECSYS IGFBP-3
• Common Device Name: RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE
• 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: 15933869
• Report Number: 1823260-2022-03917
• Device Sequence Number: 4347264
• Product Code: CFL
• UDI-Device Identifier: 07613336142677
• UDI-Public: 07613336142677
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup,Followup
• Report Date (Section B): 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 07574690190
• Device Lot Number: ASKU
• 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: 11/07/2022
• Supplement Date Received by Manufacturer: 12/13/2022; 12/19/2022; 03/11/2023
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 01/10/2023; 01/18/2023; 04/07/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown