MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW STRATUS CS

Catalog Number 10453531

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 05/18/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Customer should not have run patient samples when qc failed on the instrument.Customer confirmed that none of the patients were affected by the bias and it was not clinically significant.Customer indicated that they won't be sending the product back for investigation because they no longer have the product.Siemens representative had customer replace and adjust fluorometer lamp, run sc and calibrate ((b)(4)) and run ddmr qc.Siemens customer service engineer (cse) verified fluorometer lamp, adjusted it using both customer's and his reference disk, aligned pipettor's y-alignment and all auto-alignments successfully ran system check.Cse recalibrated customer's lot ((b)(4)) using new cal pak lot ((b)(4)); reviewed and compared qc results to biorad pier data; qc within pier range.Customer agreed that issue is lot-to-lot matrix shift and agreed to change qc targets accordingly.Instrument is operational.

Event Description

Customer reported failed proficiency testing on instrument on (b)(6) 2015 and ran 13 patient samples when quality control failed on the instrument from (b)(6) 2015 through (b)(6) 2015.There was no report of injury due to this event.

• Brand Name: STRATUS CS
• Type of Device: STRATUS CS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; newark DE 19702
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; newark DE 19702
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 4932501
• MDR Text Key: 22657302
• Report Number: 1217157-2015-00106
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 10453531
• Was Device Available for Evaluation?: No Information
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1