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

Catalog Number	07027737190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas e 801 analytical unit is (b)(6).The field applications specialist (fas) and field service engineer (fse) investigated the event and performed an unsuccessful precision check.The fse found a large serum clot; the alarm trace also showed a sample clot alarm and abnormal low signal alarms.He cleaned the analyzer and performed troubleshooting.A repeat precision check was performed with unsuccessful results.The fse replaced the measuring cells and the reagent probe, and further troubleshooting was performed.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys prolactin ii assay (prol) results from two patient samples tested on the cobas e 801 analytical unit.Patient sample 1 on (b)(6) 2025, the initial result was 2.00 uiu/ml with a data flag.On (b)(6) -2025, the repeat result was 258 uiu/ml.Patient sample 2 on (b)(6) 2025, the initial result was 2.00 uiu/ml with a data flag.On (b)(6) 2025, the repeat result was 360 uiu/ml.The clinic questioned the results prompting the patient samples to be rerun.
Additional Manufacturer Narrative
The precision checks and comparison tests after the service actions were acceptable.The calibration and qc results were within specified ranges.The alarm trace had a sample clot alarm before and an abnormal low signal on the date of the event.The patient sample tube was centrifuged for 4 minutes at 4500 rpm.The recommended centrifugation settings are 10 minutes at 1800 g.The investigation determined the event was consistent with clot formation due to the short centrifugation time.A general reagent problem was not present because the qc before the event was within ranges, and isolated non-reproducible results do not represent a general malfunction of the assay.The investigation determined that the service actions resolved the issue.The investigation did not identify a product problem.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21688322
• Report Number: 1823260-2025-00870
• Device Sequence Number: 18496805
• Product Code: CFT
• UDI-Device Identifier: 04015630940097
• UDI-Public: 04015630940097
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2025

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: 765079
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown