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

Model Number	10460277
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: DIMENSION® LIPL LIPASE FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 11254444
• Report Number: 2517506-2021-00028
• Device Sequence Number: 3111161
• Product Code: CHI
• UDI-Device Identifier: 00842768025532
• UDI-Public: 00842768025532
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1