MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA®; DIMENSION VISTA® LIPL LIPASE FLEX® REAGENT CARTRIDGE

Catalog Number K3056 SMN 10461745

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) for the discordant depressed lipl results.Siemens headquarters support center (hsc) has reviewed the information provided by the customer.The customer stated that a new flex was loaded onto the instrument and qc was within range.The event is isolated to one flex reagent cartridge of lot 18040ba.Using a new flex resolved the issue.No error flags were generated at the time of testing.Hsc is not able to determine the cause of the low recovery with this flex.Instrument data is not available.There is no evidence of a product non-conformance.The system is working as specified with the new flex.The cause is unknown.The device is operating within specifications.No further evaluation of the device is required.

Event Description

Discordant falsely depressed lipase (lipl) results were obtained on qc and patient samples on the dimension vista 500 system.The results were reported to the physician(s).The patient samples were reprocessed due to qc being out of laboratory ranges.Higher results and within range qc values were obtained on the same samples on an alternate dimension vista and on reprocessing on the original dimension vista with a new flex reagent cartridge from the same lot.Corrected patient results were reported.There are no reports of treatment change or adverse health consequences to the patients due to the discordant falsely depressed lipl results.

• Brand Name: DIMENSION VISTA®
• Type of Device: DIMENSION VISTA® LIPL LIPASE 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 ; 3026318356
• MDR Report Key: 7915178
• MDR Text Key: 122173132
• Report Number: 2517506-2018-00546
• Device Sequence Number: 1
• Product Code: CHI
• UDI-Device Identifier: 00842768020223
• UDI-Public: 00842768020223
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/27/2018

1 Device was Involved in the Event

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 Expiration Date: 11/06/2018
• Device Catalogue Number: K3056 SMN 10461745
• Device Lot Number: 18040BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2018
• Initial Date FDA Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/09/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1