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

Catalog Number 09289275190

Device Problems High Test Results (2457); Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi) #: (b)(4).Some calibration signals were below the expected range.Samples with larger volumes, showed good reproducibility when re-run.The customer¿s qc results were acceptable.A general reagent issue can be excluded.Based on the data provided, the investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter repeated approximately 2,000 research patient samples from (b)(6) 2019 tested for elecsys anti-sars-cov-2 s (anti-sars-cov-2 s) on a cobas e801 module and the results for 7 patient samples were discrepant.The initial results from (b)(6) 2019 were positive; upon repeating the patient samples, the results for 7 patient samples were negative.The customer stated the volume was low on these samples.No questionable results were reported outside of the laboratory.It is not known if pcr testing was performed.No pcr test results have been provided.The e801 module serial number was (b)(4).

• Brand Name: ELECSYS ANTI-SARS-COV-2
• 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: 11348837
• MDR Text Key: 268347373
• Report Number: 1823260-2021-00514
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 09289275190
• Device Lot Number: 51595101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2021
• 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