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

Catalog Number 09203095190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The customer's qc values were acceptable before patient testing.The investigation is ongoing.

Event Description

The initial reporter received a questionable result for one patient sample tested with the elecsys anti-sars-cov-2 assay on a cobas e411 rack serial number (b)(4).It is unknown whether the elecsys anti-sars-cov-2 result was reported outside the lab.The patient¿s elecsys anti-sars-cov-2 result was 7.27 coi reactive.The customer performed further testing with the patient¿s sample using the diasorin 5 assay, abbott rapid test, and prima p rapid test.The patient¿s sample tested negative for the diasorin 5 assay, abbott rapid test, and prima p rapid test.It is unknown whether the diasorin 5 assay, abbott rapid test, and prima p rapid test are on the list of (b)(4) products.The patient was previously tested with pcr methodology on (b)(6) 2020.The patient¿s pcr results were negative.

Manufacturer Narrative

The patient's sample was provided for an investigation.The investigation confirmed the customer's results.The investigation determined the patient's sample showed weak reactivity in both elecsys anti-sars-cov-2 assays and a weak igg reactivity with another rapid assay.Therefore, the sample was considered a true positive for antibodies against sars-cov-2.Further clarification of the observed discrepancies is not possible with available methods.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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
• MDR Report Key: 10592381
• MDR Text Key: 208744719
• Report Number: 1823260-2020-02369
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 09203095190
• Device Lot Number: 499300
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1