MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION VISTA® LOCI CA 19-9

Model Number 10464358

Device Problem High Test Results (2457)

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

Event Date 02/22/2016

Event Type  malfunction  

Manufacturer Narrative

Analysis of the instrument and instrument data indicate that the cause for the questioned elevated ca 19-9 result on one individual patient sample is unknown.The sample was run as part of a lot 15212bb to lot 15314bd comparison study.There is a small variation of internal qc results with the new lot of ca 19-9 reagent (15314bd) but strong variations with one individual patient sample on (b)(6) 2016, versus an earlier result with the sample run at an earlier date (b)(6) 2016 with an older lot of ca 19-9 reagent (15218bb).There were a range of lower percentage variations on other patient samples run on the same comparison study.This discrepancy was seen (elevated results for this individual patient sample) on two vista instruments ((b)(4)).The issue is suggestive of a patient sample specific issue.The results with the two lots were obtained on different days ((b)(6) 2016 versus (b)(6) 2016).The instrument is performing within specifications.No further evaluation of the device is required.

Event Description

The customer noted discrepant elevated ca 19-9 results on an individual patient sample on two dimension vista instruments.The results were obtained in a lot to lot comparison study (lot 15218bb vs.Lot 15314bd).It is unknown if results were reported to physicians.The result obtained (b)(6) 2016 was questioned by the account relative to a prior lower result obtained with the sample run on an earlier date ((b)(6) 2016) with an alternate lot (15218bb) of ca 19-9 reagent.The elevated result with the newer lot (15314bd) of reagent was regarded as discrepant.There is no indication that patient treatment was altered or prescribed on the basis of the questioned elevated ca 19-9 result.There was no report of adverse health consequences as a result of the questioned elevated ca 19-9 result.

• Brand Name: DIMENSION VISTA® LOCI CA 19-9
• Type of Device: DIMENSION VISTA® LOCI CA 19-9
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• Manufacturer Contact: james morgera ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 5511462
• MDR Text Key: 40733057
• Report Number: 2517506-2016-00187
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K100375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 11/09/2016
• Device Model Number: 10464358
• Device Catalogue Number: K6457
• Device Lot Number: 15314BD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/11/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1