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

Catalog Number	07027737190
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer sent 13 randomly selected patient samples for investigation.The patient samples were tested for prolactin ii and the investigation confirmed the customer's results (except for sample id (b)(6) with a result that was consistent with a sample mixup).Patient samples with results >324 uiu/ml were treated with polyethylene glycol (peg) and six showed abnormal results.The investigation confirmed the presence of macro prolactin in the patient samples.A general reagent issue was excluded in the investigation laboratory as the qc recovery was within specifications.The investigation determined that the customer's method comparison had a limited number of randomly selected samples.The investigation determined that the method comparison data showed that the analyzer's results correlated well with the siemens immulite results.The customer did not perform the mandatory peg pretreatment for the compared sample.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 did not identify a product problem.
Additional Manufacturer Narrative
The serial number of the cobas e 801 analytical unit is (b)(6).The patient samples were received for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys prolactin ii assay (prol) results from an unspecified number of patient samples tested on the cobas e 801 analytical unit.The questionable results were reported outside of the laboratory.The reporter performed a comparison test over the assay's entire measurement range.The aliquoted patient samples were sent to another laboratory that uses the siemens immulite analyzer (chemiluminescence laboratory method).Please refer to the attachment pt-0069285 for the table containing 19 patient samples with questionable results.

• 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: 19497257
• Report Number: 1823260-2024-01709
• Device Sequence Number: 7833303
• Product Code: CFT
• UDI-Device Identifier: 04015630940097
• UDI-Public: 04015630940097
• Combination Product (Y/N): Y
• Initial Reporter Country: GR
• 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): 08/02/2024

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 Expiration Date: 05/31/2025
• 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: 05/20/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 08/02/2024
• 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