MAUDE Adverse Event Report: ROCHE DIAGNOSTICS IGF-1 ELECSYS COBAS E 100; 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	11/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The specific growth hormone being administered, dosage and weight was provided for each patient.Refer to attachment for the additional information.
Event or Problem Description
The initial reporter questioned results tested for igf-1 elecsys cobas e 100 (igf-1) on a cobas e 411 immunoassay analyzer.A physician questioned results for an unspecified number of patient samples not matching their clinical picture.It was noted that this was only observed with patients being supplemented by growth hormones.Six patient samples were tested on the e411 analyzer and the immulite analyzer.Of the 6 samples, the results for 4 patient samples were either discrepant when compared to the immulite or the results did not correspond to the patient¿s clinical condition as determined by the reference ranges for the respective assays.Refer to attached data for the patient results, gender and age.The physician believed the results from the immulite analyzer to be correct.The questionable results from the e411 analyzer were reported outside of the laboratory.(b)(4).
Additional Manufacturer Narrative
The samples were requested for investigation.
Additional Manufacturer Narrative
The patient samples were submitted for investigation and tested with retention reagent lot number 56955201 (the same as used by the customer).Calibration and qc on this lot was acceptable.The following results were obtained: "patient 3" (female, 8 years): 412 ng/ml "patient 4" (male, 13 years): 491 ng/ml "patient 5" (female, 14 years): 434 ng/ml "patient 6" (male, 15 years): 719 ng/ml based on these results, a general reagent issue was not identified.The investigation is ongoing.
Additional Manufacturer Narrative
The patients were being administered either nordiflex, saizen and genotropin.To assess an interference, the investigation performed experiments on these drugs and did not identify any significant interference or co-detection.The customer's igf-1 results were confirmed.Further clarification of the discrepant results is not possible with available methods and the current state of the art.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: IGF-1 ELECSYS COBAS E 100
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12923342
• Report Number: 1823260-2021-03571
• Device Sequence Number: 5647667
• Product Code: CFL
• UDI-Device Identifier: 07613336143131
• UDI-Public: 07613336143131
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (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,Followup,Followup
• Report Date (Section B): 04/11/2022

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 Expiration Date: 07/31/2022
• Device Model Number: IGF-1
• Device Catalogue Number: 07475896190
• Device Lot Number: 56955201
• 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: 11/12/2021
• Supplement Date Received by Manufacturer: 12/16/2021; 02/25/2022; 03/18/2022
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 12/28/2021; 03/19/2022; 04/11/2022
• 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 Age: 8 YR
• Patient Sex: Female
• Patient Weight: 21 KG