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

Catalog Number 07574690190

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2023

Event Type  malfunction  

Event 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.

Manufacturer Narrative

The analyzer serial number is (b)(6).The investigation is ongoing.

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
• Type of Device: 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
• MDR Text Key: 320677260
• Report Number: 1823260-2023-02521
• Device Sequence Number: 1
• Product Code: CFL
• UDI-Device Identifier: 07613336142677
• UDI-Public: 07613336142677
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Sex: Male