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

Catalog Number 09203095190

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Calibration and qc data was requested but not provided.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." based on the available data, a general reagent issue could be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter received questionable elecsys anti-sars-cov-2 results for one patient tested on a cobas 6000 e 601 module serial number (b)(4).On (b)(6) 2020, the patient tested positive for pcr methodology.On (b)(6) 2020, the patient had a blood sample drawn.The customer performed testing with a covid 2 igg and igm rapid test.The manufacturer of the covid 2 igg and igm rapid tests were requested but not provided.The patient¿s rapid test results were igg negative and igm positive.On 25-jun-2020, the blood sample was further tested with the elecsys anti-sars-cov-2 assay and had a result of 0.057 coi non-reactive.The customer performed repeat testing with the covid 2 igg and igm rapid test.The patient¿s rapid test results were igg negative, and the igm positive.

• 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: 10328376
• MDR Text Key: 200833854
• Report Number: 1823260-2020-01801
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 09203095190
• Device Lot Number: 49546401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2020
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1