MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS CLINITEK ADVANTUS; CT ADVANTUS

Catalog Number 10283060

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 06/15/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Customer has been recommended to replace platform and hold down plate and provided with applicable part numbers to order.Customer has been contacted to check if they have had further issues.Customer does not want direct contact.Customer will not be returning sample/reagent for investigation.The cause for the discordant results is unknown.

Event Description

Customer stated that instrument reported discordant leukocytes, rbc and protein results.There was no report of injury due to this event.

Manufacturer Narrative

Customer did not return sample for investigation.Proper technique and maintenance has been reviewed with the customer.After performing maintenance customer ran 10 samples.All positives correlated with visual reading.Siemens customer care center has reached out to customer 3 times to follow up but the customer has not responded.There is no evidence that a siemens product is not meeting specifications.

• Brand Name: CLINITEK ADVANTUS
• Type of Device: CT ADVANTUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown 10591
• Manufacturer (Section G): KIMBALL ELECRONICS; ul. pozenanska 1/c; poland sp.z o.o; tarnowo podgorne, 6208 0; PL 62080
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 4912475
• MDR Text Key: 22388180
• Report Number: 1217157-2015-00099
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/17/2015

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: Other
• Device Catalogue Number: 10283060
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2015
• Initial Date FDA Received: 07/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1