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

Catalog Number 09289267190

Device Problem Low Test Results (2458)

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

Event Date 03/21/2022

Event Type  malfunction  

Manufacturer Narrative

The results were not used for diagnostic purposes.The results were collected exclusively for study purposes.The samples were requested to be returned for investigation.Product labeling indicates a negative (non-reactive) anti-sars-cov-2-s is a result of < 0.80 u/ml and a positive (reactive) result is = 0.80 u/ml - = 250 u/ml and > 250 u/ml.The investigation is ongoing.

Event Description

There was an allegation of questionable non-reactive elecsys anti-sars-cov-2 s results for 2 patient samples on a cobas e 411 analyzer (rack system), serial number (b)(4).Patient 1: on (b)(6) 2022 the patient's symptomatic infection was confirmed by a pcr test.On (b)(6) 2022 the patient's results were: the elecsys anti-sars-cov-2 result was 18 coi (reactive).The elecsys anti-sars-cov-2 s result was 17.5 u/ml (non-reactive).Patient 2: on (b)(6) 2022 the patient's symptomatic infection was confirmed by a pcr test.On (b)(6) 2022 the patient's results were: the elecsys anti-sars-cov-2 result was 37.86 coi (reactive).The elecsys anti-sars-cov-2 s result was <0.4 u/ml (non-reactive).It is unknown if the results were reported outside of the laboratory.

Manufacturer Narrative

Samples from both patients were returned for investigation.Investigation results: (a) the elecsys anti-sars-cov-2 results were: the result for patient #1 was 18.7 coi.The result for patient #2 was 64.3 coi.Both samples were reactive.(b) the elecsys anti-sars-cov-2 s results with the wuhan receptor binding domains (rbd) were: the result for patient #1 was 17.8 u/ml.The result for patient #2 was 3.44 u/ml.Both samples were reactive.(c) the elecsys anti-sars-cov-2 s (omicron rbd) results were: the result for patient#1 was 52.9 u/ml.The result for patient #2 was 30.5 u/ml.Both samples were reactive.The customer's results were confirmed.Consequently, the omicron and the wuhan rbds were compared in the elecsys anti-sars-cov-2 s assay.Higher titers were detected by the omicron rbd in both patient samples.It is unclear, whether the omicron rbd would have detected an earlier seroconversion in the samples collected within one month after the infection from the unvaccinated patients.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: 14521844
• MDR Text Key: 300629945
• Report Number: 1823260-2022-01520
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EUA202698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09289267190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2022
• 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
• Patient Sex: Male