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

Model Number	IGF-1
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys igf-1 results for 18 patients tested with a cobas e411 disk.Based on the provided data, the igf results for six patients were discrepant.Prior to patient testing, the customer confirms that calibration and qc have been acceptable.The elecsys igf results were reported outside the laboratory.Due to the results not matching the clinical picture of the patients, the patients have a new sample collected and tested at a different laboratory and with a siemens immulite 2000.The customer determined the siemens results were correct.Sample identifier (b)(6) had an elecsys igf result of 204.8 ng/ml.The patient's siemens immulite igf result was 149 ng/ml.Sample identifier (b)(6) had an elecsys igf result of 699.5 ng/ml.The patient's siemens immulite igf result was 517 ng/ml.Sample identifier (b)(6) had an elecsys igf result of 553.3 ng/ml.The patient's siemens immulite igf result was 411 ng/ml.Sample identifier (b)(6) had an elecsys igf result of 395.4 ng/ml.The patient's siemens immulite igf result was 297 ng/ml.Sample identifier (b)(6) had an elecsys igf result of 858.5 ng/ml.The patient's siemens immulite igf result was 607 ng/ml.Sample identifier (b)(6) had an elecsys igf result of 883.3 ng/ml.The patient's siemens immulite igf result was 671 ng/ml.The e411 serial number was (b)(4).
Additional Manufacturer Narrative
Medwatch field "d4 - lot no" was updated.
Additional Manufacturer Narrative
The patient samples were received for investigation.The investigation determined that the samples did not show extremely high values but were in the range of 145 - 575 ng/ml.The customer's reported result of 858.5 ng/ml was not observed in the results obtained by the investigation.The highest measured result was 575.6 ng/ml.The investigation was unable to confirm the customer's complaint.The calibration, qc and instrument data were requested but not provided.The investigation did not identify a product problem.The cause of the event could not be determined. .

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15117092
• Report Number: 1823260-2022-02210
• Device Sequence Number: 5666724
• Product Code: CFL
• UDI-Device Identifier: 07613336143131
• UDI-Public: 07613336143131
• Combination Product (Y/N): N
• 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): 09/29/2022

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 Model Number: IGF-1
• Device Catalogue Number: 07475896190
• Device Lot Number: 61445601
• 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: 07/04/2022
• Supplement Date Received by Manufacturer: 08/10/2022; 09/05/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 09/01/2022; 09/29/2022
• 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