MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CALCITONIN; CALCITONIN TEST SYSTEM

Catalog Number 09005676190

Device Problem High Test Results (2457)

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

Event Date 02/07/2024

Event Type  malfunction  

Manufacturer Narrative

The serial number of the e601 analyzer is (b)(6).The investigation is ongoing.

Event Description

The initial reporter stated they received questionable results for one patient sample tested with elecsys calcitonin on a cobas 6000 e601 module.A sample collected from the patient on (b)(6) 2024 resulted in a calcitonin value of 1.6 pg/ml.A sample collected from the patient on (b)(6) 2024 resulted in a calcitonin value of 12 pg/ml.This value was reproduced when the sample was repeated.The customer alleges the value was abnormally high and suspects the sample may contain an interfering factor against a component of the calcitonin assay.A sample collected from the patient on (b)(6) 2024 resulted in a calcitonin value of 6.0 pg/ml and it repeated as 6.2 pg/ml.

Manufacturer Narrative

The customer confirmed that the issue did not occur with the elecsys calcitonin.The correct reagent used is (b)(6) pct.The questionable results were procalcitonin results.Medwatch fields d1, d2, d4, g1, and g4 have been updated.

Manufacturer Narrative

D4 expiration date was updated.The investigation did not identify a specific product problem.The cause of the event could not be determined.Based on the calibration and qc data, there was no evidence of a reagent or instrument problem.

• Brand Name: ELECSYS CALCITONIN
• Type of Device: CALCITONIN TEST SYSTEM
• 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 46250-0457
• MDR Report Key: 18796437
• MDR Text Key: 336438275
• Report Number: 1823260-2024-00570
• Device Sequence Number: 1
• Product Code: JKR
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: K192815
• 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: 05/08/2024
• 2 Devices were Involved in the Event: 1 2

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: 09005676190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 03/12/2024; 04/23/2024
• Supplement Dates FDA Received: 04/03/2024; 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1