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

Model Number	DF56
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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®
• Common Device Name: DIMENSION® LIPASE (LIPL) FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark, de
• MDR Report Key: 9996264
• Report Number: 2517506-2020-00138
• Device Sequence Number: 3387111
• Product Code: CHI
• UDI-Device Identifier: 00842768025532
• UDI-Public: 00842768025532
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 04/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1