MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FREE PSA IMMUNOASSAY; TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CA

Catalog Number	03289788160
Medical Device Problem Codes	Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys total psa immunoassay and elecsys free psa immunoassay results for one patient sample tested on the cobas e 411 immunoassay analyzer with serial number (b)(4).This medwatch will apply to the free psa assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the total psa assay.The reporter reran a previous total psa sample and included the free psa in the run.The free psa result was noted to be higher than the total psa result.The results were reported outside of the laboratory.The total psa result was 0.024 ng/ml.The free psa was 0.5 ng/ml.
Additional Manufacturer Narrative
The field service engineer (fse) performed preventive maintenance.The customer was sent a new reagent and calibrators.Calibration and qc were performed with acceptable results.The patient's sample was reran and the results were reported to be acceptable.After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.

• Brand Name: ELECSYS FREE PSA IMMUNOASSAY
• Common Device Name: TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CA
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13059980
• Report Number: 1823260-2021-03830
• Device Sequence Number: 3912227
• Product Code: MTG
• UDI-Device Identifier: 07613336154397
• UDI-Public: 07613336154397
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2021

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: 05/31/2022
• Device Catalogue Number: 03289788160
• Device Lot Number: 52938101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "INSULIN NOVULINK"; ALBUTEROL; AVODART; AZITHROMYCIN; BENICAR; CRESTOR; FLOMAX; JANUMET; OZEMPIC
• Patient Age: 60 YR
• Patient Sex: Male