MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. DIMENSION®; CALCIUM FLEX® REAGENT CARTRIDGE

Model Number DIMENSION®

Device Problem Low Test Results (2458)

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

Event Date 10/22/2021

Event Type  malfunction  

Event Description

A falsely depressed discordant calcium (ca) patient sample result was obtained on the dimension® exl¿ 200 system.The patient result was reported to the physician.The patient sample was reprocessed using a different reagent lot and a higher result was obtained.The customer did not issue a corrected report.There are no known reports of patient intervention or adverse health consequences due to the reported event.

Manufacturer Narrative

A united states customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding a discordant, falsely depressed result on a patient sample obtained on a dimension® exl¿ 200 system.Siemens is investigating the event.

Manufacturer Narrative

Additional information (01-dec-2021): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc has reviewed the information provided by the customer and the instrument data logs.Hsc concluded that there is no evidence of a product non-conformance with the assay or the dimension exl 200 system.Calcium quality control (qc) results were within expected ranges.The cause of the event is unknown.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation initial mdr 2517506-2021-00321 was filed on 17-nov-2021.

• Brand Name: DIMENSION®
• Type of Device: CALCIUM FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer Contact: james morgera ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 12832467
• MDR Text Key: 282038502
• Report Number: 2517506-2021-00321
• Device Sequence Number: 1
• Product Code: CIC
• UDI-Device Identifier: 00842768014123
• UDI-Public: 00842768014123
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K860021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/02/2022
• Device Model Number: DIMENSION®
• Device Catalogue Number: DF23A /SMN 10444949
• Device Lot Number: FA2214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1