MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA); TOTAL,PROSTATE SPECIFIC ANTIGEN FOR DETECTION OF PROSTATE CANCER

Catalog Number 04641655190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter questioned low results for multiple patients tested for elecsys total psa immunoassay (total psa) on a cobas e 411 immunoassay analyzer.The customer provided an example for 1 patient with an initial result from the e411 analyzer of 0.002 ng/ml with a data flag.The sample was repeated twice at a different laboratory using the cobas 6000 e 601 module with results of 0.158 ng/ml and 0.157 ng/ml.The repeat results were believed to be correct based on the previous results for this patient and that the patient had a recent prostate carcinoma operation.The results were reported outside of the laboratory.There was no allegation that an adverse event occurred.The e411 analyzer serial number was (b)(4).The customer pulled patient samples from the last 8 weeks (50 samples) and repeated them.Discrepant results were identified for all 50 samples.Refer to attached data for these results.The customer believes the issue was caused by a calibration issue from (b)(6) 2019.A field service engineer (fse) visited the customer site and performed new calibration and the customer has had no further issues.

Manufacturer Narrative

The customer's calibration data shows calibration signals that were too high on (b)(6) 2019 and (b)(6) 2019.The new calibration performed on (b)(6) 2019 showed normal signals.The reason for the high calibration signals is not known.This may be related to incorrect handling of the calibrators.The customer's qc data was within the acceptable range for the reagent lot specific target values.The customer used 15 mm sample tubes with no rack adapters.Product labeling instructs the user to use 13 mm sample tubes with the e411 instrument.Based on the information provided, a general reagent issue is not suspected.A general product problem has been excluded.The malfunction is consistent with bad calibration at the customer site; the issue was solved after new calibration was performed.

• Brand Name: TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA)
• Type of Device: TOTAL,PROSTATE SPECIFIC ANTIGEN FOR DETECTION OF PROSTATE CANCER
• 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: 8428346
• MDR Text Key: 139087456
• Report Number: 1823260-2019-01109
• Device Sequence Number: 1
• Product Code: MTF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P990056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 04641655190
• Device Lot Number: 35107401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2019
• Initial Date FDA Received: 03/18/2019
• Supplement Dates Manufacturer Received: 02/27/2019
• Supplement Dates FDA Received: 04/29/2019
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1