MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-SARS-COV-2 S; CORONAVIRUS SEROLOGICAL REAGENT

Catalog Number 09289267190

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 01/15/2022

Event Type  malfunction  

Event Description

There was a complaint of questionable elecsys anti-sars-cov-2 s results for 1 patient tested with cobas e411 rack serial number (b)(4).The questionable results were not reported outside the laboratory.The patient¿s initial result was (b)(6); the first repeat was (b)(6), and the second repeat was (b)(6).The units of measurement were requested but not provided.

Manufacturer Narrative

The customer reported that the qc was within the manufacturer's range on the day of the event.The field service engineer (fse) found the patient's sample was clear with no fibrin observed.The fse checked the pinch valve tubings and found them slightly over-clamped.The investigation is ongoing.

Manufacturer Narrative

The unit of measure for the anti-sars-cov-2 s results was u/ml.Calibration was last performed on (b)(6)2022 and was acceptable.No issues were identified during a review of the alarm trace data.Based on the information provided, a general reagent issue can be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS ANTI-SARS-COV-2 S
• Type of Device: CORONAVIRUS SEROLOGICAL REAGENT
• 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: 13545818
• MDR Text Key: 292966941
• Report Number: 1823260-2022-00402
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: EUA202698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 09289267190
• Device Lot Number: 57270701
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/15/2022
• 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