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

Catalog Number 07475969190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

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

Event Date 12/07/2022

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 325859724
• Report Number: 1823260-2023-03321
• Device Sequence Number: 1
• Product Code: CFL
• UDI-Device Identifier: 07613336143148
• UDI-Public: 07613336143148
• Combination Product (y/n): Y
• Reporter Country Code: BR
• 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: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07475969190
• Device Lot Number: 00701491
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Sex: Male