MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS IGF-1; RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE

Catalog Number	07475918190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys igf-1 assay results for 1 patient sample on a cobas e 801 module compared to a siemens immulite.On (b)(6) 2022, the igf-1 result was 89 nmol/l.On (b)(6) 2022, the siemens igf-1 result was 60 nmol/l.The exact date of testing was requested but not provided.On (b)(6) 2022, the sample was repeated on the e801 module and the result was 94 nmol/l.The roche reference range is 15 - 64 nmol/l.The siemens reference range is 23 - 66 nmol/l.No questionable results were reported outside of the laboratory.The e801 module serial number is (b)(4).
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
An aliquot of the patient sample initially reported was provided for investigation.The investigation obtained a roche igf-1 result of 94 nmol/l and a siemens immulite result of 52 nmol/l.The sample was tested using a diasorin analyzer for igf-1.The result was 607.2 ng/ml (79.4 nmol/l).The diasorin reference range for this patient is 83 - 519 ng/ml (10.9 - 67.9 nmol/l).This patient was also reported to be taking norditropin (somatropin).Per product labeling, ".The following special growth disorder drugs were tested.No interference with the assay was found: somatropin - 3.0 mg/l concentration." two additional samples from a second patient were also sent for investigation.Patient 2 is male, 15 years old.The investigation obtained a roche igf-1 result of 46 nmol/l and a siemens immulite result of 29 nmol/l from the first sample.The investigation obtained a roche igf-1 result of 59 nmol/l and a siemens immulite result of 39 nmol/l from the second sample.The roche reference range for patient 2 is 16 - 65 nmol/l.The siemens reference range was requested but not provided.Patient 2's second sample was tested using a diasorin analyzer and the result was 446.0 ng/ml (58.3 nmol/l).The diasorin reference range for patient 2 is 102-520 ng/ml (13.3 - 67.9 nmol/l).The investigation confirmed the recovery of the elecsys igf-1 assay with another competitor method and the who standard.The investigation did not identify a product problem.

• Brand Name: ELECSYS IGF-1
• 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: 15729514
• Report Number: 1823260-2022-03489
• Device Sequence Number: 14171311
• Product Code: CFL
• UDI-Device Identifier: 07613336140864
• UDI-Public: 07613336140864
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2023

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: 02/28/2023
• Device Catalogue Number: 07475918190
• Device Lot Number: 61446801
• 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: 10/11/2022
• Supplement Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 03/08/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GROWTH HORMONE; NORDITROPIN (PATIENT 1)
• Patient Age: 14 YR
• Patient Sex: Male