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

Catalog Number	07475918190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 8000 core unit serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with elecsys igf-1 assay on a cobas 8000 core unit.Initial result: 1232 ng/ml.The customer questioned the initial result as it did not match the patient's clinical diagnosis and repeated the sample.No questionable result was reported outside the laboratory.Repeat result: 940 ng/ml.The repeat result was deemed to be correct and reported to the clinic.
Additional Manufacturer Narrative
The calibration signal performed on 19-jun-2025 was low.A test for the reagent pack (a new reagent pack was used) was performed using the frozen reconstituted calibration solution; the signals were significantly higher.The investigation did not identify a problem with the reagent pack.The investigation found that the customer's qc material was refrigerated after opening and not frozen; an issue with the detection of qc deviations is likely.The investigation determined the event was consistent with an issue with the particular reagent pack used at the time of the event.The investigation did not identify a product problem.The specific cause of the event could not be determined.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22920613
• Report Number: 1823260-2025-02662
• Device Sequence Number: 9144262
• Product Code: CFL
• UDI-Device Identifier: 07613336140864
• UDI-Public: 07613336140864
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/26/2025

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: 12/31/2025
• Device Catalogue Number: 07475918190
• Device Lot Number: 85364401
• 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: 08/05/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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