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

Model Number	10460277
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) and reported an elevated lipase (lipl) patient result was obtained and questioned as discordant on a dimension exl 200 system.Siemens is investigating the event.
Event or Problem Description
An elevated lipase (lipl) result, questioned as discordant, was obtained on a patient sample on a dimension exl 200 system.The result was reported to the physician(s).The patient was hospitalized.A new sample drawn within 24 hours was processed on an alternate non-siemens system and a lower result, within the normal range for that methodology, was obtained, considered correct, and reported.There are no known reports of patient intervention or adverse health consequences due to the discordant falsely elevated lipase result or the hospitalization.
Additional Manufacturer Narrative
Mdr 2517506-2020-00187 was filed 24-jun-2020.Additional information 29-jun-2020: siemens headquarters support center (hsc) completed the investigation of the falsely elevated lipase (lipl) event.Hsc has reviewed the information provided and the instrument data logs and has observed no product non-conformance.Quality control (qc) was within range on the day of testing.Hsc is not able to determine the cause of the elevated lipl results on this patient sample.Hsc investigation shows this is patient specific and not a systemic issue.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: DIMENSION® LIPASE (LIPL) FLEX® REAGENT CARTRIDGE,
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark, de
• MDR Report Key: 10192461
• Report Number: 2517506-2020-00187
• Device Sequence Number: 19041430
• Product Code: CHI
• UDI-Device Identifier: 00842768025532
• UDI-Public: 00842768025532
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 07/22/2020

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: 09/02/2020
• Device Model Number: 10460277
• Device Catalogue Number: DF56 SMN 10460277
• Device Lot Number: GC0246
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR