MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS PROLACTIN II; RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)

Catalog Number 07027737190

Device Problems Low Test Results (2458); Insufficient Information (3190)

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

Event Date 04/07/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys prolactin ii results for one patient tested on a cobas 8000 e 801 module with a serial number (b)(4).The customer confirmed the qc results were acceptable.The patient's initial result was reported outside the laboratory.The patient's physician questioned the reported result due to the result not matching the patient's clinical picture.The customer performed dilution testing with the patient's sample on the same e 801 module.It was reported the prolactin result "gradually becomes larger the more it is diluted." the patient's initial prolactin result was 14.3 ng/ml.The patient's prolactin result with a 1:2 dilution was 14.4 ng/ml.The patient's prolactin result with a 1:4 dilution was 14.7 ng/ml.The patient's prolactin result with a 1:8 dilution was 13.8 ng/ml.The patient's prolactin result with a 1:10 dilution was 15.2 ng/ml.The patient's prolactin result with a 1:40 dilution was 20.0 ng/ml.The patient's prolactin result with a 1:80 dilution was 25 ng/ml.The patient's prolactin result with a 1:100 dilution was 110 ng/ml.The patient's prolactin result with a 1:10000 dilution was 900 ng/ml.The customer "predicts the patient's sample has a prolactin concentration of greater than 13,000 ng/ml.".

Manufacturer Narrative

Further information regarding the event was requested but not provided by the customer.Based on the provided information, the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS PROLACTIN II
• Type of Device: RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14268587
• MDR Text Key: 299490707
• Report Number: 1823260-2022-01238
• Device Sequence Number: 1
• Product Code: CFT
• UDI-Device Identifier: 04015630940097
• UDI-Public: 04015630940097
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07027737190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2022
• 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 Sex: Male