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

Catalog Number 03203093190

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

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

Event Date 08/16/2022

Event Type  malfunction  

Event Description

The initial reporter received a questionable elecsys prolactin assay result for two samples from the same patient tested on the cobas 6000 e601 module with serial number (b)(4).The results allegedly did not match the patient's clinical picture.The initial result was reported to the patient.The patient questioned the result as they did not match with another laboratory's result that uses a siemen's system.The patient was not able to provide the details of this result.A new patient sample was then collected from the patient.This sample was also run and rerun in the module.It also was sent to a pathology service laboratory that uses a cobas e 801 to confirm the reporter's result.It was also sent for correlation and investigation to a reference laboratory that uses a cobas e 411.The reporter also reran the primary and secondary tubes of the initial patient sample to confirm that there was no patient sample mix-up.The patient again went to another hospital laboratory and obtained a different result.The doctor believed the result from this laboratory was the true value and stated that the prl results should not have had a big difference in a short period of time.The new patient sample collected by the reporter's laboratory was then sent out to this hospital laboratory for another rerun.The hospital laboratory uses a cobas e 601.Refer to the attachment in the medwatch for the questionable results.

Manufacturer Narrative

The local investigation concluded that the customer's high prl result from the new sample collected on (b)(6) 2022 was compatible with other roche platforms.They did not identify any reagent, calibrator or hardware issues.The investigation determined that the calibration signals were a little bit higher but were acceptable.The qc was within the specified ranges.Prolactin is secreted pulsatile in episodes.There can be significant differences if a sample was drawn at a positive peak level and another sample was drawn shortly before secretion.Product labeling states "when determining prolactin it should be remembered that the measured concentration is dependent upon when the blood sample was taken, since the secretion of prolactin occurs in episodes and is also subject to a 24-hour cycle." the investigation did not identify a product problem.The cause of the event could not be determined.

• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15628498
• MDR Text Key: 307037618
• Report Number: 1823260-2022-03235
• Device Sequence Number: 1
• Product Code: CFT
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K964748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 03203093190
• Device Lot Number: 592684
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2022
• 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 Age: 29 YR
• Patient Sex: Female