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 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter complained of discrepant results between 2 reagent lots for 1 patient sample tested for elecsys anti-sars-cov-2 (anti-sars-cov-2) on a cobas 6000 e 601 module.The initial result with reagent lot 507260 (expiration date not provided) was 0.9 coi (negative).A previously frozen aliquot from the primary tube was run 1 month later on (b)(6) 2020 with reagent lot 51233901 expiration date 31-dec-2020 and the result was 1.33 coi (positive).The negative result had been reported outside of the laboratory.The e601 module serial number was (b)(4).

Manufacturer Narrative

Reagent lot 507260 has an expiration date of 30-nov-2020.With both lots, the patient sample result was very close to the cutoff.Qc recovery for both lots was within specification.Based on the calibration and qc data provided, a general reagent issue can be excluded.For samples close to the cutoff, result variations may be observed when measuring with two different reagent lot numbers.The specific cause of the event could not be determined.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: 10871779
• MDR Text Key: 243069764
• Report Number: 1823260-2020-02952
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 09203095190
• Device Lot Number: 51233901, 507260
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2020
• 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
• Patient Sequence Number: 1