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

Catalog Number	07475896190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas 6000 e601 module is (b)(6).The patient sample was received for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys igf-1 assay results from one patient sample tested on the cobas 6000 e601 module.On (b)(6) 2024: the initial result of the undiluted patient sample from the module was 103.6 ng/ml.On (b)(6) 2024: the first repeat result of the undiluted patient sample from the module was 80.1 ng/ml.On (b)(6) 2024: the second repeat result of the undiluted patient sample from the module was 81.5 ng/ml.The third repeat result of the undiluted patient sample from the module was 96.90 ng/ml.This result was deemed low and was disputed by the doctor.The patient sample was sent to a subcontractor laboratory that uses euroimmun and immulite 2000 xpi analyzers.Both analyzers use the chemiluminescent immunoassay (clia) laboratory method.The fourth repeat result of the undiluted patient sample from the euroimmun analyzer was 488.2 ng/ml.The fifth repeat result of the undiluted patient sample from an immulite 2000 xpi analyzer was 381.00 ng/ml.The repeat results using the clia method correlated with the patient's clinical condition.On (b)(6) 2024: the sixth repeat result of the undiluted patient sample from the module was 129.6 ng/ml.The seventh repeat result with the patient sample at 1:5 dilution was 34.74 ng/ml (with a final calculated dilution result of 173.7 ng/ml).The seventh repeat result with the patient sample at 1:10 dilution was 65.62 ng/ml (with a final calculated dilution result of 656.2 ng/ml).
Additional Manufacturer Narrative
The investigation was able to confirm the customer's igf-1 result.The investigation tested the patient sample for igfbp-3 and a result above the reference range was obtained which was in line with the patient's symptoms.The investigation determined the event was consistent with an interference in the patient sample.The investigation did not identify a product problem.
Additional Manufacturer Narrative
Product labeling states "for diagnostic purposes, the results should always be assessed in conjunction with the patient´s medical history, clinical examination and other findings.".

• Brand Name: ELECSYS IGF-1
• Common Device Name: HUMAN GROWTH HORMONE ASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18809659
• Report Number: 1823260-2024-00605
• Device Sequence Number: 20656603
• Product Code: CFL
• UDI-Device Identifier: 07613336143131
• UDI-Public: 07613336143131
• Combination Product (Y/N): Y
• Initial Reporter Country: PL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2024

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: 07/31/2024
• Device Catalogue Number: 07475896190
• Device Lot Number: 74330900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: 04/23/2024; 05/27/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 05/10/2024; 05/29/2024
• 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: 65 YR
• Patient Sex: Male