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

Catalog Number 09203095190

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2020

Event Type  malfunction  

Manufacturer Narrative

The qc and calibrations were within acceptable limits.The euroimmun iga-assay is not on the list of eua (emergency use authorization) products.This event occurred in (b)(6).The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys anti-sars-cov-2 results for 1 positive covid-19 patient on a cobas 6000 e601 module, serial number (b)(4).On (b)(6) 2020, the patient sample produced a positive result of 1.08 coi using the elecsys anti-sars-cov-2 method.The sample was retested on a different analyzer using the same method.The sample produced another positive result of 1.48 coi.The same sample was tested using the euroimmun iga-assay and produced a negative result of 0.43 coi.The same sample was tested using the euroimmun igg-assay and produced a negative result of 0.34 coi.The same sample was also tested using the diasorin igg-assay and the sample produced a result of < 0.43 coi.The results were not reported outside of the laboratory.It is unknown which results are believed to be correct.

Manufacturer Narrative

The customer's sample was returned for investigation.The customer's result for the sample was reproducible with the elecsys anti-sars-cov-2 assay.Additional measurements were performed with a rapid assay from creative diagnostics as well as an independent in-house roche assay detecting other antibodies against sars-cov-2.A weak igm reactivity was detected in the rapid assay, whereas igg resulted non-reactive.Similarly, the roche in-house assay showed weak reactivity, however, below the cutoff level.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.

• 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: 10242046
• MDR Text Key: 202550156
• Report Number: 1823260-2020-01627
• 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: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 09203095190
• Device Lot Number: 49629801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1