MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS IGFBP-3; RADIOIMMUNOASSAY, HUMAN GROWTH HORMONE

Catalog Number	07574690190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys igfbp-3 results for 8 patient samples on a cobas e 411 immunoassay analyzer.The doctor questioned the results as they did not meet the patients' clinical pictures.On (b)(6) 2023, patient 1 had an igfbp-3 result of 4493 ng/ml.On (b)(6) 2023, patient 2 had an igfbp-3 result of 4650 ng/ml.On (b)(6) 2023, patient 3 had an igfbp-3 result of 2279 ng/ml.On (b)(6) 2023, patient 4 had an igfbp-3 result of 3227 ng/ml.On (b)(6) 2023, patient 5 had an igfbp-3 result of 1171 ng/ml.On (b)(6) 2023, patient 6 had an igfbp-3 result of 5436 ng/ml.On (b)(6) 2023, patient 7 had an igfbp-3 result of 3022 ng/ml.On (b)(6) 2023, patient 8 had an igfbp-3 result of 5124 ng/ml.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The customer used a new calibrator lot to recalibrate and the qc data stabilized.The customer changed their workflow and calibration schedule.The customer is now calibrating before running patient samples as it appears to give control results closer to the target value.No issues have been reported since the changes were implemented.The investigation did not identify a product problem.

• Brand Name: ELECSYS IGFBP-3
• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg)
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250-0457
• MDR Report Key: 17465221
• Report Number: 1823260-2023-02521
• Device Sequence Number: 2905006
• Product Code: CFL
• UDI-Device Identifier: 07613336142677
• UDI-Public: 07613336142677
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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): 08/31/2023

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 Expiration Date: 12/31/2023
• Device Catalogue Number: 07574690190
• Device Lot Number: 70526201
• 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: 07/10/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 08/31/2023
• 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 Age: 15 YR
• Patient Sex: Male