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

Model Number 10460277

Device Problem Low Test Results (2458)

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

Event Date 01/02/2021

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the falsely depressed lipase result.The patient sample was lipemic and had been flagged by the instrument as lipemic.No other patient samples were reported to be similarly affected.The cause of the difference in results between the dimension xpand plus with hm and the alternate non-siemens instrument is attributed to the sample lipemia.There is no indication of a lipase assay non-conformance based on the quality control (qc) performance.The device is performing within specifications.No further evaluation is required.

Event Description

A discordant, falsely depressed lipase (lipl) result was obtained on a patient sample on a dimension xpand plus with hm system.The result was not reported to the physician.A new sample was drawn the same day and processed on a non-siemens system by an alternate methodology.An elevated result, considered correct, was obtained 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® 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: 11254444
• MDR Text Key: 234475344
• Report Number: 2517506-2021-00028
• Device Sequence Number: 1
• Product Code: CHI
• UDI-Device Identifier: 00842768025532
• UDI-Public: 00842768025532
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/29/2021

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: 03/29/2021
• Device Model Number: 10460277
• Device Catalogue Number: DF56 SMN 10460277
• Device Lot Number: GC1088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 01/29/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/15/2020
• 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