MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION®; CREATININE CRE2 FLEX® REAGENT CARTRIDGE,

Model Number	10872079
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted siemens healthcare diagnostics customer care center (ccc) to report elevated results were obtained with creatinine (cre2) on a single patient sample on two dimension® exl¿ 200 integrated chemistry systems when compared to an alternate siemens instrument with alternate methodology.Siemens is investigating the event.
Event or Problem Description
An elevated creatinine (cre2) patient sample result was obtained on two dimension® exl¿ 200 integrated chemistry systems when compared to a creatinine result on the same sample processed with an alternate methodology on an alternate siemens system.The results from both systems were reported to the physician(s) who questioned the difference in results.The customer does not consider any of the results to be discordant.No corrected reports were issued.The patient was admitted to the facility based on the cre2 results from the dimension exl systems.There are no known reports of patient intervention, unnecessary treatment or adverse health consequences due to the cre2 results from the dimension exl systems or the admission to the hospital.
Additional Manufacturer Narrative
Initial mdr 2517507-2021-00291 was filed 21-oct-2021.Additional information (29-oct-2021): siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the elevated creatinine (cre2) results on two dimension® exl¿ 200 integrated chemistry systems when compared to a creatinine result on the same sample processed with an alternate methodology on an alternate siemens system.Hsc reviewed the information provided by the customer.Quality control was in range and no issues were noted with other patient samples indicating that the instrument and assay were performing acceptably.A potential product issue has not been identified.The cause of the event is unknown.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.

• Brand Name: DIMENSION®
• Common Device Name: CREATININE CRE2 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 - BROOKFIELD; registration number: 1226181; 101 silvermine road; brookfield CT 06804 6101
• Manufacturer Contact: james morgera ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 12672346
• Report Number: 2517506-2021-00291
• Device Sequence Number: 4480290
• Product Code: CGX
• UDI-Device Identifier: 00630414595009
• UDI-Public: 00630414595009
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K132638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 11/16/2021

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: 06/30/2022
• Device Model Number: 10872079
• Device Catalogue Number: CRE2 SMN 10872079
• Device Lot Number: FA2181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female