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

Catalog Number	07027737190
Medical Device Problem Codes	Low Test Results (2458); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem 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.".
Additional 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
• Common Device Name: 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
• Report Number: 1823260-2022-01238
• Device Sequence Number: 17353669
• Product Code: CFT
• UDI-Device Identifier: 04015630940097
• UDI-Public: 04015630940097
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K964748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2022

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 Catalogue Number: 07027737190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 05/03/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Male