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

Catalog Number 09289267190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/31/2021

Event Type  malfunction  

Manufacturer Narrative

The calibration and qc were reported to be within specifications.The patient's sample was retrieved and upon site visit, fibrins were noted on the side of the tube.The investigation is ongoing.

Event Description

The initial reporter received a questionable elecsys anti-sars-cov-2 s result for one patient sample tested on a cobas e411 rack analyzer with serial number (b)(4).The initial result at 6:30 pm was 0.400 u/ml with a data flag.The repeat result at 7:07 pm was 250 u/ml with a data flag.The repeat result at 7:33 pm was 250 u/ml with a data flag.The initial result was not reported outside of the laboratory as they have a protocol to rerun samples with results of 0.400 u/ml with a data flag.

Manufacturer Narrative

Medwatch fields d4 lot no.And d4 - expiration date were updated.

Manufacturer Narrative

The investigation determined that the fibrin in the sample caused the false low result.The investigation did not identify a product problem.

• Brand Name: ELECSYS ANTI-SARS-COV-2 S
• 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: 13426373
• MDR Text Key: 287272094
• Report Number: 1823260-2022-00278
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: EUA202698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 09289267190
• Device Lot Number: 57270701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2022
• 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