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

Catalog Number 07027737190

Device Problems High Test Results (2457); Low Test Results (2458)

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

Event Date 06/28/2021

Event Type  malfunction  

Manufacturer Narrative

Both the customer and investigation results were above the reference range leading to the same clinical interpretation.Product labeling states: "in case of implausible high prolactin values a precipitation by polyethylene glycol (peg) is recommended in order to estimate the amount of the biological active monomeric prolactin." peg treatment was not performed.A general reagent issue can be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter questioned a result for 1 patient sample tested for elecsys prolactin ii (prolactin ii) on a cobas e801 module.The initial result from the customer¿s e801 module was 44 ng/ml.This result was reported outside of the laboratory where the physician requested additional testing.The sample was submitted for investigation where the result from an e801 module used at the investigation site was 57.8 ng/ml.The e801 module serial number used at the customer site is not known.The e801 module used at the investigation site was (b)(4).The prolactin ii reagent lot used at the investigation site was 482648 with an expiration date of nov-2021.

• Brand Name: ELECSYS PROLACTIN ASSAY
• 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: 12244543
• MDR Text Key: 272659554
• Report Number: 1823260-2021-02207
• Device Sequence Number: 1
• Product Code: CFT
• UDI-Device Identifier: 04015630940097
• UDI-Public: 04015630940097
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K964748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• 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: 07/12/2021
• 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