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

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to siemens that they obtained erroneously elevated lipase (lip) results on two (2) patient samples when the samples were reprocessed on a dimension exl with lm system.The erroneously elevated results were not reported to the physician(s).New samples were drawn from the same patients and processed on the original dimension exl with lm system.Lower results were obtained, considered correct, and reported.For the second patient, another new sample was drawn and processed on the original dimension exl with lm system.A lower result was obtained, considered correct, and reported.The customer stated that the patients were admitted to the hospital based on the erroneously elevated lip results.No treatment was given or delayed and the patients were discharged from the hospital without any harm.There are no known reports of adverse health consequences due to the erroneously elevated lipase (lip) results.
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding erroneously elevated lipase (lip) results on two (2) patient samples obtained when the samples were reprocessed on a dimension exl with lm system.Siemens is investigating the event.The customer obtained erroneously elevated lipase (lip) results on the same two (2) patient samples when the samples were initially processed on (b)(6) 2024 on the original dimension exl with lm system.An additional mdr was filed for this event.
Additional Manufacturer Narrative
Additional information (19-aug-2024): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the instrument data files and the information provided by the customer.Quality control (qc) recovery was within the customer¿s expected ranges and the calibration was acceptable.The review of the instrument data indicated dirty windows.The customer stated there were no additional issues observed with the lipase (lip) patient samples.Based on the available information, the cause of the event is unknown.The customer is operational.The device is performing according to specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2517506-2024-00147 was filed on 15-may-2024.Initial mdr 2517506-2024-00146 was filed on 15-may-2024 for the event that occurred on 22-apr-2024.Supplemental mdr 2517506-2024-00146 supplement 1 was filed for the event that occurred on 22-apr-2024.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® 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: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 19319191
• Report Number: 2517506-2024-00147
• Device Sequence Number: 7577843
• Product Code: CHI
• UDI-Device Identifier: 00630414292748
• UDI-Public: 00630414292748
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2024

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: 11/17/2024
• Device Model Number: N/A
• Device Catalogue Number: SMN DF56A 11538126
• Device Lot Number: FB4322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown