MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TESTOSTERONE II ASSAY; RADIOIMMUNOASSAY, TESTOSTERONE

Catalog Number 07027915190

Device Problem High Test Results (2457)

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

Event Date 04/22/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Udi number = (b)(4).

Event Description

The initial reporter stated they received a discrepant result for one patient sample tested with the elecsys testosterone ii assay on an unknown roche analyzer.The results did not compare to results obtained with the lcmsms method.The sample resulted with a testosterone value of 5.7 nmol/l and repeated as 4.9 nmol/l when tested using the elecsys testosterone assay.The sample was tested using the lcmsms method, resulting in a value of 0.32 nmol/l.

Manufacturer Narrative

Samples from the patient were provided for investigation.The testosterone measurements of the samples were found to be higher than the reference range for people younger than 18 years.Further investigations of the samples determined they do not contain interfering factor against the streptavidin component of the testosterone assay.Investigations are ongoing.

Manufacturer Narrative

Further investigations of the samples determined they do not contain interfering factor against the ruthenium component of the testosterone assay.A biotin interference could also be excluded.The investigation could not identify a product problem.The cause of the event could not be determined.A general reagent issue can likely be excluded.Medwatch field d4.Has been updated.

• Brand Name: ELECSYS TESTOSTERONE II ASSAY
• Type of Device: RADIOIMMUNOASSAY, TESTOSTERONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11869466
• MDR Text Key: 252156348
• Report Number: 1823260-2021-01526
• Device Sequence Number: 1
• Product Code: CDZ
• Combination Product (y/n): N
• PMA/PMN Number: K093421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07027915190
• Device Lot Number: 472593
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 15 YR