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

Catalog Number 09203079190

Device Problem False Negative Result (1225)

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

Event Date 02/11/2022

Event Type  malfunction  

Manufacturer Narrative

Product labeling states: "the sensitivity of the elecsys anti-sars-cov-2 assay early after infection is unknown.Negative results do not preclude acute sars-cov-2 infection.If acute infection is suspected, direct testing for sars-cov-2 is necessary." the investigation is ongoing.

Event Description

The initial reporter complained of a questionable negative result for 1 patient tested for elecsys anti-sars-cov-2 (anti-sars-cov-2) on a cobas e 801 analytical unit with serial number (b)(4).The questionable result was reported outside of the laboratory.(b)(6).

Manufacturer Narrative

Section d4, expiration date was updated.The investigation determined that the elecsys anti-sars-cov-2 results were as expected.Product labeling states: "a negative test result does not completely rule out the possibility of an infection with sars-cov-2.Serum or plasma samples from the very early (pre-seroconversion) phase can yield negative findings.Therefore, this test cannot be used to diagnose an acute infection.Also, over time, titers may decline and eventually become negative." the investigation did not identify a product problem.

• 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: 14398978
• MDR Text Key: 293336321
• Report Number: 1823260-2022-01388
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: EUA200514
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 09203079190
• Device Lot Number: 59782601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2022
• 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 Age: 37 YR
• Patient Sex: Female