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

Catalog Number DF56 SMN 10460277

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) for the discordant elevated lipl result obtained on the initial sample on the dimension exl system.Siemens headquarters support center (hsc) has reviewed the instrument data and completed their evaluation.Hsc does not suspect an instrument or reagent issue as qc is very consistent.System checks were all within range.No product non-conformances were identified.The cause is unknown.The system is operating within specifications.No further evaluation of the device is required.

Event Description

A discordant elevated lipase (lipl) result was obtained on a patient sample on the dimension exl 200 system.The result was reported to the physician who questioned the result.The patient had a new sample drawn at a later time on the same date and a lower result was obtained and reported.No corrected report was issued.The patient was admitted based on the symptoms and laboratory result of the elevated lipase for evaluation and fluids (suspected pancreatitis).The patient was given nacl iv fluids.There are no reports of adverse health consequences due to the discordant elevated lipl result or treatment.

Manufacturer Narrative

Original mdr was filed 04-jun-2018.Additional information (06-jun-2018): the customer provided additional patient data obtained when the samples were initially processed earlier on same date, (b)(6) 2018.First sample lipl result (b)(6) 2018 = 1,255 u/l (discordant).Sample initially processed (b)(6) 2018, obtained: 1,242 u/l.Second sample lipl result (b)(6) 2018 = 168 u/l (note: sample drawn 12 hours after the first sample).Sample initially processed (b)(6) 2018, obtained: 164 u/l.

• Brand Name: DIMENSION®
• Type of Device: 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: 7565063
• MDR Text Key: 109910599
• Report Number: 2517506-2018-00356
• Device Sequence Number: 1
• Product Code: CHI
• UDI-Device Identifier: 00842768025532
• UDI-Public: 00842768025532
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/03/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2018
• Device Catalogue Number: DF56 SMN 10460277
• Device Lot Number: GC8317
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/09/2018
• Initial Date FDA Received: 06/04/2018
• Supplement Dates Manufacturer Received: 06/06/2018
• Supplement Dates FDA Received: 07/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1