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

Catalog Number 07027737190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

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

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

This investigation is ongoing.This event occurred in (b)(6).Unique identifier (udi) #: (b)(4).

Event Description

The initial reporter received a questionable elecsys prolactin assay result for one patient with the cobas e 801 module serial number (b)(4) compared to a chemiluminescence method.Note: the units of measure were not provided for the following results.(b)(6).The questionable result was reported outside of the laboratory.It is unclear which result is deemed correct and whether the measurements were performed on the same sample.

Manufacturer Narrative

The calibration and qc data were requested but not provided.The investigation found the customer did not perform a polyethylene glycol precipitation (peg) for implausible high samples.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.The investigation determined the discrepancy is due to not following recommended procedures.This is considered improper pre-analytical handling by not performing the peg treatment.The investigation did not identify a product problem.

• Brand Name: ELECSYS PROLACTIN ASSAY
• Type of Device: RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11704122
• MDR Text Key: 269789090
• Report Number: 1823260-2021-01204
• Device Sequence Number: 1
• Product Code: CFT
• Combination Product (y/n): N
• PMA/PMN Number: K964748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 07027737190
• Device Lot Number: 482648
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR