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

Model Number DF56

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant, falsely depressed lipase (lipl) result on a dimension exl system.Siemens hsc has reviewed the information provided by the customer and the dimension exl instrument data.The cause of the event is attributable to operator error in making the 1/3 dilution that generated the erroneous result.There is no indication of a assay or instrument malfunction.The customer is operational.The device is performing within specifications.No further evaluation is required.

Event Description

A discordant, falsely depressed lipase (lipl) result was obtained on a diluted patient sample on a dimension exl system.The result was reported to the physician(s).The same sample was reprocessed on an alternate dimension exl and a higher result was obtained, considered correct, and reported.There are no known reports of patient intervention or adverse health consequences due to the discordant falsely depressed lipase result.

• Brand Name: DIMENSION®
• Type of Device: DIMENSION® LIPASE (LIPL) FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark, de
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark, de
• Manufacturer Contact: james morgera ; 500 gbc drive; po box 6101; newark, de ; 6318356
• MDR Report Key: 9996264
• MDR Text Key: 195158355
• Report Number: 2517506-2020-00138
• Device Sequence Number: 1
• Product Code: CHI
• UDI-Device Identifier: 00842768025532
• UDI-Public: 00842768025532
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 04/24/2020

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: 07/15/2020
• Device Model Number: DF56
• Device Catalogue Number: SMN 10460277
• Device Lot Number: GC0197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2020
• Initial Date FDA Received: 04/24/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/23/2019
• 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