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

Catalog Number 07027737190

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 12/02/2023

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys prolactin ii on a cobas e 801 analytical unit.The sample initially resulted in a prolactin value of 870 uiu/ml.The sample was treated with polyethylene glycol (peg) and repeated.The result was higher than the initial value.No specific value was provided.Since the peg treated value was higher, the sample was repeated two additional times on (b)(6) 2023, resulting in prolactin values of 1430 uiu/ml and 1416 uiu/ml.

Manufacturer Narrative

The serial number of the e801 analyzer is (b)(6).The investigation is ongoing.

Manufacturer Narrative

Calibration data was within expectations.Quality controls recovered within range.A reagent issue was not present since controls before the event were within range.Upon review of the alarm trace, no relevant alarms were observed.The field service engineer checked and cleaned dirty reagent probes, sipper nozzles, and pre-wash nozzles.The analyzer was often giving degasser low-pressure errors, so the degasser pump was replaced.The investigation determined the service actions resolved the issue.The operator is required to clean all probes and nozzles daily.

• 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): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18334878
• MDR Text Key: 331057307
• Report Number: 1823260-2023-04025
• Device Sequence Number: 1
• Product Code: CFT
• UDI-Device Identifier: 04015630940097
• UDI-Public: 04015630940097
• Combination Product (y/n): Y
• Reporter Country Code: RO
• PMA/PMN Number: K060373
• 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,Followup,Followup
• Report Date: 01/16/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• 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: 716142
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1