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

Catalog Number	07475969190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 6000 e601 module serial number was (b)(6).The expiration date of igf-1 reagent was not provided.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 3 patients' samples tested with elecsys igf-1 assay on a cobas 6000 e601 immunoassay analyzer when compared to a support laboratory using chemiluminescence methodology.Sample 1 (patient 1): on (b)(6) 2022: initial result: 668 ng/ml.On (b)(6) 2022: repeat result: 437 ng/ml.Sample 2 (patient 2): on (b)(6) 2022: initial result: 687.5 ng/ml.On (b)(6) 2022: repeat result: 383 ng/ml.Sample 3 (patient 3): on (b)(6) 2023: initial result: 403.6 ng/ml.On (b)(6) 2023: repeat result: 293 ng/ml.
Additional Manufacturer Narrative
All the patients tested by the roche method were above the reference range.According to the reference range provided for the unspecified chemiluminescence method, the results were within the reference range.As the competitor's chemiluminescence method was not known, the cause of the event could not be determined.The investigation did not identify a product problem.

• 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 46250-0457
• MDR Report Key: 17950531
• Report Number: 1823260-2023-03321
• Device Sequence Number: 6715528
• Product Code: CFL
• UDI-Device Identifier: 07613336143148
• UDI-Public: 07613336143148
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 11/29/2023

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 Catalogue Number: 07475969190
• Device Lot Number: 00701491
• 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: 09/21/2023
• Supplement Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 11/29/2023
• 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
• Patient Age: 13 YR
• Patient Sex: Male