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

Catalog Number K3056 (SMN # 10461745)

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/20/2017

Event Type  malfunction  

Manufacturer Narrative

Customer contacted siemens customer care center (ccc) and accepted remote access.Ccc determined that the low lipl results occurred with lipl flex reagent cartridge sequence number 6829 in wellmap 1:7.Ccc directed customer to replace the reagent cartridge with another reagent cartridge from the same lot and run qc.Qc passes and customer reran lipl on patient samples and issued corrected reports on eleven of the fifteen samples that were rerun.The cause of low lipl results on the affected reagent cartridge is unknown.The instrument is performing within specifications.No further evaluation of the device is required.

Event Description

Discordant lipase (lipl) results were obtained on qc and patient samples on the dimension vista 500 system.Patient results were reported to physician(s) while qc was out of range.There is no indication that patient results were questioned by the physician(s).After recalibration and passing qc results, the same patient samples were repeated on the same system.Corrected reports were issued on eleven of the fifteen samples.There are no known reports of patient intervention or adverse health consequences due to the initially discordant lipl results.

• Brand Name: DIMENSION VISTA® LIPASE FLEX® REAGENT CARTRIDGE
• Type of Device: DIMENSION VISTA® LIPL
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC - GLASGOW; glasgow business community; 500 gbc drive po box 6101; newark DE 19714 6101
• Manufacturer Contact: edward szymanski ; glasgow business community; 500 gbc drive po box 6101; newark, DE 19714-6101 ; 3026317672
• MDR Report Key: 6489543
• MDR Text Key: 72944966
• Report Number: 2517506-2017-00359
• Device Sequence Number: 1
• Product Code: CHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/13/2017

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: 03/24/2017
• Device Catalogue Number: K3056 (SMN # 10461745)
• Device Lot Number: 16179BC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2017
• Initial Date FDA Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/27/2016
• 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