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

Catalog Number 10636672

Device Problems Data Problem (3196); Patient Data Problem (3197)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2014

Event Type  malfunction  

Event Description

Customer reported that instrument erroneously run 3 patient samples in a row with the same patient id.There was no report of injury due to this event.

Manufacturer Narrative

Customer indicated that they are not aware of any results being mis-reported to a physician due to this.They caught it and deleted the patient id.The cause of the event is unknown.

Manufacturer Narrative

Siemens headquarter service center (hsc) team indicated that customer's barcode reader was configured to do automatic carriage return.Customer was scanning the patient id, then the color and clarity from a barcode sheet.The instrument prompted them to place the strip but they were then scanning the 'enter' barcode on the color/clarity sheet (required if they didn't have auto carriage return) which loads that block of information (pat id, color and clarity) again.Siemens customer care center (ccc) had spoken with customer who indicated that they are no longer having this issue.Moreover customer also indicated that the issue occurred with only certain staff members who were scanning the 'enter arrow' barcode.Since these operators have stopped scanning this barcode they have had no further problems with wrong patient id's being reported.Instrument is performing as intended.

• 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: 4274203
• MDR Text Key: 5004139
• Report Number: 1217157-2014-00177
• 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: 10/27/2014

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: 10636672
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2015
• Initial Date FDA Received: 11/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/12/2015
• Is the Device Single Use?: No
• Patient Sequence Number: 1