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 08/28/2020

Event Type  malfunction  

Manufacturer Narrative

The reporter also mentioned they were having issues with results from pooled patient material used as a negative quality control.With reagent lot number 499300, results were non-reactive, but with reagent lot 507260, the results were reactive.Pooled patient material used as a positive control also showed an increase in values with lot 507260.Calibration signals recovered within expected ranges.The pooled patient material used as negative control and complained patient sample recovered values near the cutoff index of the assay (1.00).The investigation determined that the sensitivity and specificity claims are met.A general reagent issue can be excluded.No product problem found.Per product labeling, "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." this event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with two lot numbers of the elecsys anti-sars-cov-2 assay on the cobas 6000 e 601 module.It is not known which result was considered to be correct.The patient sample was tested using reagent lot 499300, resulting with a value of 0.974 coi (non-reactive).This value was reported outside of the laboratory to the patient.The patient sample was tested using reagent lot 507260 on (b)(6) 2020, resulting with a value of 1.34 coi (reactive).The patient sample was repeated using reagent lot 507260 on (b)(6) 2020, resulting with a value of 1.37 coi (reactive).The e 601 analyzer serial number is (b)(4).

• 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: 10593128
• MDR Text Key: 208970138
• Report Number: 1823260-2020-02378
• 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
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09203095190
• Device Lot Number: 499300, 507260
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2020
• Initial Date FDA Received: 09/28/2020
• 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