MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDPOINT 500; RP 500

Catalog Number 10492730

Device Problem Device Expiration Issue (1216)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The log file received from the customer for the investigation was from after the software was upgraded from v2.2b to v2.2.2b.This wiped the information required to investigate.Customer has been requested to provide a log file that was obtained 3/27.Siemens field service engineer (fse) replaced measurement, automatic quality control (aqc) and washed cartridges which fixed the problem.System is operational.

Event Description

Customer reported that cartridge status showed erroneous expiry days count.Measurement cartridge s/n (b)(4) with 3014 days remaining and which expires on 6/28 and 74 samples analyzed.Aqc cartridge s/n (b)(4) with 5968 days remaining expires on 7/30 and 128 samples analyzed both cartridges were installed on (b)(6) 2016.There was no report of injury due to this event.

• Brand Name: RAPIDPOINT 500
• Type of Device: RP 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.; northern road; chilton industry; sudbury CO10 2XQ; UK CO10 2XQ
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 5605053
• MDR Text Key: 44339171
• Report Number: 1217157-2016-00044
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 10492730
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1