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

Catalog Number 03289788160

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/29/2021

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 288664859
• Report Number: 1823260-2021-03830
• Device Sequence Number: 1
• Product Code: MTG
• UDI-Device Identifier: 07613336154397
• UDI-Public: 07613336154397
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/29/2021
• 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
• Treatment: "INSULIN NOVULINK"; ALBUTEROL; AVODART; AZITHROMYCIN; BENICAR; CRESTOR; FLOMAX; JANUMET; OZEMPIC
• Patient Age: 60 YR
• Patient Sex: Male