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

Catalog Number 09203079190

Device Problems False Negative Result (1225); Non Reproducible Results (4029)

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

Event Date 12/12/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the cobas e 801 module is (b)(6).The investigation is ongoing.

Event Description

The initial reporter received a questionable elecsys anti-sars-cov-2 s (anti-sars-cov-2 s) result from a patient sample tested on a cobas e 801 module.The patient sample was rerun as part of troubleshooting.On (b)(6) 2023: the initial result was 0.202 (negative).On (b)(6) 2023: the repeat result was 2.18 (positive).The result was confirmed as positive with a third run.The unit of measurement was not provided.

Manufacturer Narrative

Medwatch field d4 lot no and expiration date was updated.The investigation reviewed the calibration data on (b)(6) 2023; the results were within specifications.There was no influence of the calibration on the event.The investigation reviewed the qc data; the results were within specifications for both positive and negative controls before the patient sample was run and before the module was released for patient measurement.The investigation reviewed the alarm trace from the date of the event; no issues were noted.The investigation reviewed the customer's handling of patient samples.The customer's centrifugation time and force were below the recommended settings by the tube manufacturer.The investigation excluded a general reagent problem because the qc before the event was within range.The investigation determined the event was consistent with a preanalytic issue at the customer site (the customer's centrifugation settings were below the recommended settings).

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18507810
• MDR Text Key: 333328959
• Report Number: 1823260-2024-00135
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): Y
• Reporter Country Code: EI
• PMA/PMN Number: EUA200514
• 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
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 09203079190
• Device Lot Number: 739532
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• 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