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

Catalog Number 09289267190

Device Problem Low Test Results (2458)

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

Event Date 07/21/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys anti-sars-cov-2 s results for two patients tested on a cobas 6000 e 601 module serial number (b)(4).It was requested but not provided if the initial elecsys anti-sars-cov-2 s results were reported outside the laboratory.The customer performed repeat testing with the samples prior to calibration and after calibration, and the results for both samples had increasing values.For repeat testing, the customer did recentrifuge the samples.At 15:34, patient 1's initial elecsys anti-sars-cov-2 s result was 0.400 u/ml with a data flag and non-reactive.The patient's repeat results before calibration were 17 u/ml reactive and 29 u/ml reactive.The patient's result after calibration was 38.73 u/ml reactive.At 15:34, patient 2's initial elecsys anti-sars-cov-2 s result was 0.400 u/ml with a data flag and non-reactive.The patient's repeat result before calibration was 1.99 u/ml reactive.The patient's result after calibration was 2.23 u/ml reactive.

Manufacturer Narrative

Calibration, qc, pre-analytical and instrument data were submitted and analyzed.Pre-analytical or reagent handling could not be excluded due to the limited information submitted.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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
• MDR Report Key: 12313731
• MDR Text Key: 266252776
• Report Number: 1823260-2021-02353
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• PMA/PMN Number: EUA202698
• 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: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 09289267190
• Device Lot Number: 548617
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: METFORMIN (PATIENT 1); NEBILET (PATIENT 1); NOVALGIN (PATIENT 1); PANTOPRAZOL (PATIENT 1); SALBUTAMOL (PATIENT 1); METFORMIN (PATIENT 1); NEBILET (PATIENT 1); NOVALGIN (PATIENT 1); PANTOPRAZOL (PATIENT 1); SALBUTAMOL (PATIENT 1)
• Patient Age: 78 YR